Wednesday, November 30, 2005

Cellulitis and Skin Infections

Cellulitis & Skin Infections

Cellulitis is a spreading infection of the skin extending to involve the subcutaneous tissues. The most common causes are group A b -haemolytic streptococci (GABHS) and Staphylococcus aureus. Predisposing factors include skin abrasions, lacerations, burns, eczematous skin, etc, although the portal of entry of organisms is often not seen.

Allergic reactions / contact dermatitis (e.g. to insect bites, immunisations, plants, etc) are frequently misdiagnosed as cellulitis. If there is itchiness and no tenderness, cellulitis is unlikely.

Erysipelas is a specific superficial form of cellulitis usually caused by GABHS. There may be lymphatic involvement.

Impetigo (commonly called "school sores") is a highly contagious infection of the epidermis, particularly common in young children. Causative organisms are GABHS and S. aureus.

Staphylococcal scalded skin syndrome (SSSS) is a blistering skin disorder induced by the exfoliative (epidermolytic) toxins of S. aureus. It primarily affects neonates and young children.

Necrotising fasciitis is a rapidly progressive soft tissue infection characterised by necrosis of subcutaneous tissue. Aetiology is often polymicrobial. Causative organisms include GABHS, S. aureus, anaerobes, etc. It can cause severe illness with a high mortality rate (メ 25%).


Consider herpetic infection when vesicles are present, and send appropriate specimens for immunofluorescence and viral culture.

There are many other forms of skin infection that are not covered in this guideline.

Assessment

The typical presenting features of all skin infections include soft tissue redness, warmth and swelling, but other features are variable (see table and photos below). It is difficult to distinguish between skin infections caused by GABHS and S. aureus on a clinical basis alone.

Investigations

Swab for Gram stain (slide) and culture if discharge present
FBE + blood culture if systemic symptoms present
ESR, xrays +/- bone scan if osteomyelitis suspected (See Osteomyelitis / Septic arthritis guidelines)
Ultrasound if fluctuance present


Treatment

Flucloxacillin 25 mg/kg (max 500mg) po 6H for 7 days

If severe/extensive, systemically unwell or not responding to oral treatment
flucloxacillin 50 mg/kg (max 2g) iv 6H(consider adding clindamycin if rapidly progressive to inhibit toxin production)

For facial/periorbital cellulitis: consider adding cefotaxime if: <>Periorbital cellulitis guidelines)

See complete article with diagnostic images:

Cellulitis and Skin Infections

Saturday, November 26, 2005

Necrotizing Cellulitis


Necrotizing Skin Infections

Necrotizing skin infections, including necrotizing cellulitis and necrotizing fasciitis, are severe forms of cellulitis characterized by death of infected tissue (necrosis).

Most skin infections do not result in death of skin and nearby tissues. Sometimes, however, bacterial infection can cause small blood vessels in the infected area to clot. This clotting causes the tissue fed by these vessels to die from lack of blood. Because the body's immune defenses that travel through the bloodstream (such as white blood cells and antibodies) can no longer reach this area, the infection spreads rapidly and may be difficult to control. Death is not uncommon, even with appropriate treatment.

Some necrotizing skin infections spread deep in the skin along the surface of the muscle (fascia) and are termed necrotizing fasciitis. Other necrotizing skin infections spread on the outer layers of skin and are termed necrotizing cellulitis. Several different bacteria, such as Streptococcus and Clostridia, may cause necrotizing skin infections, although in many people the infection is caused by a combination of bacteria. The streptococcal infection in particular has been termed "flesh-eating disease" by the lay press, although it differs little from the others.

Some necrotizing skin infections begin at puncture wounds or lacerations, particularly wounds contaminated with dirt and debris. Other infections begin in surgical incisions or even healthy skin. Sometimes people with diverticulitis, intestinal perforation, or tumors of the intestine develop necrotizing infections of the abdominal wall, genital area, or thighs. These infections occur when certain bacteria escape from the intestine and spread to the skin. The bacteria may initially create an abscess in the abdominal cavity and spread directly outward to the skin, or they may spread through the bloodstream to the skin and other organs.

Symptoms and Diagnosis

Symptoms often begin just as for cellulitis (see Bacterial Skin Infections: Cellulitis). The skin may look pale at first, but quickly becomes red or bronze and warm to the touch, and sometimes becomes swollen. Later, the skin turns violet, often with the development of large fluid-filled blisters (bullae). The fluid from these blisters is brown, watery, and sometimes foul smelling.

Areas of dead skin (gangrene) turn black. Some types of infection, including those produced by Clostridia and mixed bacteria, produce gas (see Bacterial Infections: Gas Gangrene). The gas creates bubbles under the skin and sometimes in the blisters themselves, causing the skin to feel crackly when pressed. Initially the infected area is painful, but as the skin dies, the nerves stop working and the area loses sensation.

The person usually feels very ill and has a fever, a rapid heart rate, and mental deterioration ranging from confusion to unconsciousness. Blood pressure may fall because of toxins secreted by the bacteria and the body's response to the infection (septic shock (see Bacteremia, Sepsis, and Septic Shock: Septic Shock).

A doctor makes a diagnosis of necrotizing skin infection based on its appearance, particularly the presence of gas bubbles under the skin. X-rays may show gas under the skin as well. The specific bacteria involved are identified by laboratory analysis of infected fluid and tissue samples. However, treatment must begin before a doctor can be certain which bacteria are causing the infection.

Treatment and Prognosis

The treatment for necrotizing fasciitis is intravenous antibiotic therapy and surgical removal of the dead tissue. Large amounts of skin, tissue, and muscle must often be removed, and in some cases, an affected arm or leg may have to be amputated. People with necrotizing infections caused by anaerobic bacteria (for example, Clostridium perfringens (see What Are Clostridia?) may benefit from treatment in a high-pressure (hyperbaric) oxygen chamber.
The overall death rate is about 30%. Older people, those who have other medical disorders, and those in whom the disease has reached an advanced stage have a poorer outcome.
Last reviewed/revised February 1, 2003


Merck

Orbital Cellulitis


Definition

Orbital cellulitis is an acute infection of the tissues immediately surrounding the eye.

Overview, Causes, & Risk Factors

Orbital cellulitis is a dangerous infection with potentially serious complications. It is usually caused by a bacterial infection from the sinuses (ethmoid or para-nasal). Other causes are a stye on the eyelid, recent trauma to the eyelid including bug bites, or a foreign object.

In children, orbital cellulitis is usually from a sinus infection and due to the organism Hemophilus influenzae. Other organisms such as Staphlococcus aureus, Streptococcus pneumoniae, and Beta hemolytic streptococci may also cause this condition.

Infants and children up through age 6 to 7 years-old seem to be particularly susceptible to infection with Hemophilus influenzae, and are most at risk. The incidence of severe disease has decreased steadily since the introduction of HiB vaccine (Hemophilus influenzae B). Risk factors include sinus infections or injury to the eyelid including bug bites.

Orbital Cellulitis Symptoms & Signs

Fever, generally 102 degrees F or greater.
Painful
swelling of upper and lower lids (upper is usually greater).
Eyelid appears shiny and is red or purple in color.
Infant or child is acutely ill or toxic.
Eye pain especially with movement.
Decreased vision (because the lid is swollen over the eye).
Eyes, bulging (forward displacement of the eye).
Swelling of the eyelids (see
facial swelling).
General
malaise.
Restricted or painful eye movements.

Orbital Cellulitis Prevention

Immunization with HiB vaccine according to recommended schedules generally will prevent most Hemophilus infection in children. Young children in the same household who have been exposed may receive the prophylactic antibiotic Rifampin, although this generally is reserved for siblings exposed to other Hemophilus diseases such as meningitis and septicemia.

Proper evaluation and early treatment of sinus, dental, or other infections may prevent the spread of infection to the eye(s).

Orbital Cellulitis Diagnosis & Tests

Tests commonly include:

A CBC (complete blood count)
Blood culture and sensitivity
A
spinal tap in extremely sick children

Other tests may include:

An X-ray of the sinuses and orbit
A
CT scan or MRI of the sinuses and orbit
A culture of eye drainage
A culture of nose drainage
A
throat culture
A blood culture

Orbital Cellulitis Treatment

Hospitalization is usually required. Treatment consists of IV fluids with antibiotics. Surgical drainage of an abscess may be necessary. These infections can progress rapidly, and they must be carefully followed every few hours.

Orbital Cellulitis Prognosis (Expectations)

With early recognition and treatment, the patient can be expected to recover fully.

Orbital Cellulitis Complications

Cavernous sinus thrombosis
Hearing loss
Septicemia or blood infection
Meningitis

Calling Your Health Care Provider

This condition is considered a major ophthalmologic emergency that requires immediate treatment. Call your physician if your child exhibits any swelling of the eyelid, especially if it is associated with fever.
Optic nerve damage and
loss of vision

See all Pictures & Images

AllRefer.comHealth

Cellulitis Overview - eMedicine Health

Cellulitis is a common infection of the skin and the soft tissues underneath the skin. It occurs when bacteria invade broken or normal skin and start to spread just under the skin or in the skin itself. This results in infection and inflammation. Inflammation is a process in which the body reacts to the bacteria. Inflammation may cause swelling, redness, pain, or warmth.

People at risk for getting cellulitis include those with trauma to the skin or other medical problems such as the following:

Diabetes
Circulatory problems such as inadequate blood flow to the limbs, poor venous or lymphatic drainage, or varicose veins
Liver disease such as chronic hepatitis or cirrhosis
Skin disorders such as eczema, psoriasis, or infectious diseases that cause skin lesions such as chickenpox or severe acne

Cellulitis Causes

Injuries that break the skin
Infections related to a surgical procedure
Any breaks in the skin that allow bacteria to invade the skin (examples are chronic skin conditions such as eczema or
psoriasis)
Foreign objects in the skin

Cellulitis Symptoms

Cellulitis can occur in almost any part of the body. Most commonly it occurs in areas that have been damaged or are inflamed for other reasons, such as inflamed lesions, contaminated cuts, and areas with poor skin condition or bad circulation. The common symptoms of cellulitis are as follows:

Redness of the skin
Red streaking of the skin or broad areas of redness
Swelling
Warmth
Pain or tenderness
Drainage or leaking of yellow clear fluid or pus from the skin
If the condition spreads to the body via the blood, then fevers and chills can result.
Infection of bone underneath the skin (An example is a long-standing open wound that is deep enough to expose the bone to bacteria. Sometimes this occurs in people with diabetes who cannot feel their feet.)

When to Seek Medical Care

Call your doctor if you have any of the following signs or symptoms of cellulitis:
Fevers or chills
Redness on the skin
Red streaks from skin
Increased warmth
Swelling
Tenderness
Drainage from the skin

Go to the hospital's emergency department if you have any signs or symptoms of cellulitis, especially the following:

High fevers or chills
Nausea and vomiting
Obvious enlargement or hardening of the reddened area
Increasing pain
Numbness of the reddened or tender area when touched
Other medical problems that may be affected by even a minor infection

Exams and Tests

Most likely the doctor will make the diagnosis from a medical history and physical examination.

The doctor may also draw blood for testing if he or she feels the infection is severe enough to be in the bloodstream.

The doctor also may order an x-ray of the area if there is concern that a foreign object is in the skin or that bone underneath is infected.

The doctor may try to draw fluid from the affected area with a needle and send the fluid to the laboratory for a culture.

Cellulitis Treatment

Self-Care at Home

Rest the area of the body involved.

Elevate the area of the body involved. This will help decrease swelling and relieve discomfort.

Use over-the-counter pain relievers such as acetaminophen (Tylenol) or ibuprofen (Motrin). This will decrease the pain as well as help keep the fever down.

Medical Treatment

If the infection is not too severe you can be treated at home. The doctor will give you a prescription for antibiotics to take by mouth for a week to 10 days.
The doctor may use intravenous (IV) or intramuscular antibiotics in these situations:
If the infection is severe
If you have other medical problems
If you are very young or very old
If the cellulitis involves extensive areas or areas close to important structures like infection around the eye socket
If the infection worsens after taking antibiotics for 2-3 days

You may need hospitalization if the infection is well developed, extensive or in an important area, like the face. In most of these cases, IV antibiotics need to be given until the infection is under good control (2-3 days) and then you can be switched to oral medications to be taken at home.

Medications

Antibiotics are prescribed by mouth or by injection. Be sure to tell your doctor about any reactions you may have had in the past to antibiotics.

Surgery

Rarely, severe infection may need surgery.
An abscess, or collection of pus in the tissue, may need to be opened surgically to allow drainage.
Dead tissue may need to be cut away to allow healing.

Follow-up

Once you leave the doctor's office, be sure to take all the antibiotics prescribed. The doctor may want to see you in 2-3 days to see if the cellulitis is improving.

Prevention

It is very important to keep your skin clean by practicing good personal hygiene.

If you notice pain or discomfort from an area of the skin, check to see what it looks like. If it appears inflamed and progresses from one day to the next, you will most likely need treatment.

Avoid situations that may injure your skin, especially if you have swelling from circulatory problems.

Wear sturdy, well-fitting shoes or slippers with loose-fitting cotton socks.

Avoid walking barefoot in areas where you do not have a good idea about what you are walking on, for example, in garages, on a littered beach, or in the woods.

If you do injure your skin wash the area with soap and water and check to make sure that the injury is getting better over the next several days.

Certain injuries may be at greater risk for infection than others. You may need to take antibiotics to prevent infection or have other preventive care. Be sure to contact your doctor if you have injuries such as these:

*Animal or human bites

*Puncture injuries deeper than a half-inch, such as stepping on a nail

*Crushed tissue that bleeds, burns that blister, frostbite, or deep injuries with dirt in them

*Injuries in contact with sea water, especially if you have liver disease

Find out if you have diabetes or other significant medical conditions, such as liver or kidney disease. These conditions may be present without symptoms. Follow your doctor's instructions for improving these conditions.

Talk to your doctor if you have swelling in your limbs that does not go away.

Outlook

Most people respond to the antibiotics in 2-3 days and begin to show improvement. In rare cases, the cellulitis may progress to a serious illness by spreading through the bloodstream. Some forms of severe cellulitis may require surgery and leave a person with scarring.

Children and Cellulitis


Cellulitis (sell-you-lite-us) is an infection of
the tissue just below the skin. Signs of cellulitis
are swelling, redness, warmth, and tenderness
of the skin. These signs can occur anywhere
on the body. Children may also develop a
fever and chills. Children with cellulitis on the
face or near a joint usually need to go to the
hospital for treatment.

The infection is caused by bacteria that may
have entered the body through an injury or a
surgical opening. The bacteria may also have
traveled through the blood from some other
site of infection such as an ear infection.

There is a higher risk of cellulitis in children
with chicken pox.

Cellulitis should be treated immediately.
Without treatment, the infection may spread
to the blood, bone, or other organs.

How do you prevent cellulitis?

Keep wounds clean and dry and wash your hands
well. Children one year or older should receive
the varicella vaccine. This will help keep your
child from getting chicken pox.

How do you treat cellulitis?

• Antibiotics may be given by mouth or
directly into a vein (through an IV).
• Acetaminophen (Tylenol®) or ibuprofen
(Advil®) may be given for fever and
discomfort. Aspirin should not be given
to children who have both chicken pox

and cellulitis (see the note at the end of
this article).
• A surgical opening may be needed to drain
the infection.
• Blood may be drawn to find the bacteria
causing the infection.
• Sometimes fluid is drawn from the infected
site through a needle. This will help find
out what antibiotics should be used.
• X-rays may be taken to find out if the
infection has spread to the bone.

Your child’s treatment and length of stay
in the hospital depend on how serious the
infection is. Children with cellulitis may stay
in the hospital up to 10 days. Children are
usually allowed to eat a regular diet and
participate in normal activities that are
comfortable for them.

Note: acetaminophen (Tylenol®) may be used
for temperature over 101°F (38.3°C). Aspirin
should NOT be given to children with chicken
pox since it may lead to a brain, liver, and
kidney disease called Reye’s syndrome.
Read the label on all medicines, including
brand names like Alka Seltzer®, to make sure
they do not contain small amounts of aspirin.
Ibuprofen is approved for children 6 months
of age and older; but it should never be
given to children who are dehydrated or
vomiting (throwing up) continuously.


Cellulitis

Pediatric Education Services
(801) 588-4060 Rev.7/03
© Primary Children’s Medical Center 2004

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Cellulitis

Kid's Health

Cellulitis is an infection of the skin and underlying tissues that can affect any area of the body. Not to be confused with cellulite - the cottage-cheese-like, lumpy fat often found on the hips, thighs, and buttocks, primarily of women - cellulitis begins in an area of broken skin, like a cut or scratch, allowing bacteria to invade and spread, causing inflammation, which includes pain, swelling, warmth, and redness.

Disorders that create breaks in the skin and allow bacteria to enter, such as eczema and severe acne, will put a child at risk for cellulitis. Chicken pox and scratched insect bites are also common causes. Cellulitis may also start in areas of intact skin, especially in people who have diabetes or who are taking medicines that suppress the immune system.

Cellulitis can be caused by many different types of bacteria, but the most common are Group A Streptococcus and Staphylococcus aureus. In special cases, other bacteria can cause cellulitis. Cellulitis after a cat or dog bite may be caused by Pasteurella multocida bacteria. Cellulitis due to Pseudomonas infection occurs after nail-puncture wounds through sneakers. Other types of bacteria from fish and farm animals can also cause cellulitis.

One specific type of cellulitis that can occur in children and requires close monitoring is periorbital cellulitis, an infection of the eyelid and tissues surrounding the eye. It can be the result of minor trauma to the area around the eye (such as an insect bite or a scratch), or it may be the extension of another site of infection, such as sinusitis. Periorbital cellulitis is treated with antibiotics and close follow-up. If untreated, it can progress to orbital cellulitis (infection of the eye orbit, or socket), a much more severe infection that results in a bulging eyeball, eye pain, restricted eye movements, or visual disturbances. This is an emergency that requires hospitalization and intravenous antibiotics.

Signs and Symptoms

Cellulitis begins as a small, inflamed area of pain, swelling, warmth, and redness on a child's skin. As this red area begins to spread, the child may begin to feel sick and develop a fever, sometimes with chills and sweats. Swollen lymph nodes (commonly called swollen glands) are sometimes found near the area of infected skin.

Contagiousness

Cellulitis is not contagious.

Prevention

You can prevent cellulitis by protecting your child's skin from cuts, bruises, and scrapes. This may not be easy, especially if you have an active child who loves to explore or play sports. Protective equipment worn to prevent other injuries during active play can also protect your child's skin: elbow and knee pads while skating, a bike helmet during bike riding, shin guards during soccer, long pants and long-sleeved shirts while hiking in the woods, sandals (not bare feet) on the beach, and seatbelts while riding in a motor vehicle.

If your child does get a scrape, wash the wound well with soap and water. Apply an antibiotic ointment and cover the wound with an adhesive bandage or gauze. Check with your child's doctor if your child has a large cut, deep puncture wound, or bite (animal or human).

Incubation

The incubation period varies, depending on the type of bacteria causing the cellulitis. For example, cellulitis caused by Pasteurella multocida has a very short incubation period - less than 24 hours after an animal bite. But other types of bacteria may have incubation periods of several days.

Duration

Cellulitis usually resolves after a few days of antibiotic therapy. However, it's very important that the child receives the medication on schedule for as many days, usually 7 to 10, as the doctor directs.

Diagnosis

Your child's doctor can usually make the diagnosis of cellulitis by asking a few questions and examining the area of affected skin. Sometimes, especially in younger children, the doctor may also order blood cultures - samples of your child's blood that are examined in the laboratory for growth of bacteria.

Positive blood cultures mean that bacteria from your child's skin infection have spread into the bloodstream, a condition known as bacteremia. This can potentially lead to septicemia, a generalized infection affecting many systems of the body. Bacteremia can also be a cause of cellulitis in certain cases.

Professional Treatment

If your child has severe cellulitis, your child's doctor may decide to treat him or her in the hospital using intravenous (IV) antibiotics.

Home Treatment

Children with milder cellulitis can be treated at home with the entire course of prescribed oral antibiotics, but with follow-up from the doctor to make sure symptoms are improving. The doctor may also suggest that the affected part of the body be immobilized and elevated to reduce swelling and pain. Using pain-relievers such as acetaminophen or ibuprofen may also help reduce discomfort.

After 1 or 2 days of antibiotics at home, your child's doctor may schedule an office visit to check that the area of cellulitis has improved and that the antibiotics are working to heal the infection.

When to Call Your Child's Doctor

Call your child's doctor whenever any area of your child's skin becomes red, warm, and painful - with or without fever and chills. This is especially important if the area of skin is on your child's face, or if your child has a chronic illness (like diabetes) or a condition that suppresses the immune system.

Because cellulitis can happen very quickly after an animal bite, call your child's doctor whenever your child is bitten by an animal, especially if the puncture wound is deep. Human bites can also cause dangerous skin infections and should be seen by a doctor. If red streaks develop from the infected area or symptoms worsen despite antibiotic treatment, your child should be reexamined.

Updated and reviewed by: Elana Pearl Ben-Joseph, MD

Date reviewed: September 2003

Originally reviewed by: Joel Klein, MD

Tuesday, November 22, 2005

Risk factors for acute cellulitis of the lower limb

Risk factors for acute cellulitis of the lower limb: a prospective case-control study.

Bjornsdottir S, Gottfredsson M, Thorisdottir AS, Gunnarsson GB, Rikardsdottir H, Kristjansson M, Hilmarsdottir I.

Department of Medicine, Division of Infectious Diseases, Landspitali University Hospital, Reykjavik, Iceland.

BACKGROUND:

Acute bacterial cellulitis is a potentially serious infection that commonly recurs. The identification of preventable risk factors could reduce infection-related morbidity and cost and improve patient management. The aim of this study was to identify the risk factors associated with lower-limb cellulitis, including both analysis of risk factors associated with cellulitis in either limb and risk factors in a single limb associated with cellulitis in the same limb. We placed particular emphasis on dermatophytic infections of the foot and bacterial infection and colonization of the toe webs.

METHODS:

We conducted a prospective case-control study of 100 subjects with cellulitis and 200 control subjects, matched for age and sex, who were admitted to a university hospital during the period October 2000-February 2004. Data were obtained with a questionnaire and from examination of lower limbs and microbiological analyses of samples from the feet.

RESULTS:

The median age of the participants was 66.5 years (interquartile range, 48.8-77.0). The following risk factors were strongly and independently associated with cellulitis: previous history of cellulitis (OR, 31.04; 95% CI, 4.15-232.20), the presence of Staphylococcus aureus and/or beta -hemolytic streptococci in the toe webs (OR, 28.97; 95% CI, 5.47-153.48), presence of leg erosions or ulcers (OR, 11.80; 95% CI, 2.47-56.33), and prior saphenectomy (OR, 8.49; 95% CI, 1.62-44.52). Tinea pedis interdigitalis was associated with cellulitis only when toe web bacteria were excluded from the analysis (OR, 3.86; 95% CI, 1.32-11.27).

CONCLUSIONS:

Risk factors for acute bacterial cellulitis in hospitalized patients include predisposing factors and the presence of sites of pathogen entry on legs and toe webs. These findings indicate that improved awareness and management of toe web intertrigo, which may harbor bacterial pathogens, and other skin lesions might reduce the incidence of cellulitis.PMID: 16231251 [PubMed - in process]

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Lymphedema People

New Antibiotic for Cellulitis

Lymphedema People

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FDA Approves Superbug Antibiotic, Tygacil (tigecycline)

MRSA/Drug Resistance News

Article Date: 17 Jun 2005

The US FDA has approved Tygacil™ (tigecycline), a novel IV antibiotic with a broad spectrum of antimicrobial activity, including activity against the drug-resistant bacteria methicillin-resistant Staphylococcus aureus (MRSA). Tygacil is indicated for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in adults. Approval of this first-in-class product comes at a time when the need for new antibiotic options to combat serious, resistant infections is increasing. “Life threatening infections are a growing concern globally,” says Dr. Joseph Camardo, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. “Bacterial infections are becoming more difficult to treat, with resistant strains on the increase. The approval of TYGACIL will provide physicians with an important option for patients with complicated skin, skin structure, and intra-abdominal infections.”

TYGACIL can be used as an empiric monotherapy to treat a variety of cIAI and cSSSI, both hospital- and community-acquired, including complicated appendicitis, infected burns, intra-abdominal abscesses, deep soft tissue infections, and infected ulcers. TYGACIL provides clinicians with a novel, broad-spectrum option that can be used at the onset of treatment when the specific bacteria present are not yet known.

In addition, TYGACIL does not require dosage adjustment in patients with impaired renal function, and is conveniently dosed every 12 hours. A Clinical ChallengeThe U.S. Centers for Disease Control and Prevention (CDC) states that persons infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with multiple drugs. The increasing prevalence of resistant bacteria often necessitates the use of combinations of antibiotics to fight infections. Antibiotic resistance costs U.S. society between $4 billion and $5 billion annually. According to the CDC, antibiotic resistance has become so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics.

Additionally, few broad-spectrum antibiotic agents are currently in development. Antibiotic development has slowed to the point that FDA has had few opportunities to approve new agents. In fact, development and approvals of new antibacterial agents have decreased by 56 percent over the past 20 years (1998-2002 vs. 1983-1987). New classes of antibiotics are needed to address increasing antibiotic resistance among common pathogens.

About TYGACIL

TYGACIL, the first antibiotic approved in a new class called glycylcyclines, was developed by Wyeth to overcome key mechanisms of resistance that have affected antibiotic use.

TYGACIL is approved for adults with complicated skin and skin structure infections (cSSSI) caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis.

TYGACIL is also approved for adults with complicated intra-abdominal infections (cIAI) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

The TYGACIL New Drug Application (NDA) submission included data from four pivotal phase III studies examining the safety and efficacy of TYGACIL for the treatment of cIAI and cSSSI. The submission also included in vitro data showing activity against both gram-negative and gram-positive bacteria, anaerobes, and certain drug-resistant pathogens.

In clinical trials, empiric monotherapy with TYGACIL provided comparable clinical cures rates in cSSSI to vancomycin and aztreonam, a combination treatment. Empiric monotherapy with TYGACIL also provided clinical cure rates comparable to imipenem/cilastatin, an empiric treatment for cIAI. The overall discontinuation rate for TYGACIL (5.0 percent) was comparable to vancomycin and aztreonam (5.3 percent) and imipenem/cilastatin (4.4 percent).

Wyeth now awaits decisions on approval of TYGACIL from other regulatory bodies around the world. TYGACIL was accepted by the European Medicines Agency (EMEA) for review, and Wyeth has filed for approval in other countries, including Brazil, Canada, Colombia, Mexico, Switzerland, Taiwan, and Venezuela. The Australian Therapeutic Goods Administration and the South African Medicines Control Council (MCC) granted priority evaluation to TYGACIL. Wyeth anticipates that TYGACIL will be available to hospitals in the U.S. in the near future.

Important Safety Information

TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline. TYGACIL should be administered with caution in patients with known hypersensitivity to, and may have adverse effects similar to, tetracycline class antibiotics. In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5 percent) and vomiting (19.7 percent).

TYGACIL may cause fetal harm when administered to a pregnant woman. The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established. Use of TYGACIL during tooth development may cause permanent discoloration of the teeth.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life threatening. Monotherapy should be used with caution in patients with clinically apparent intestinal perforation.

For a copy of TYGACIL Prescribing Information, please visit About Medical News Today

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Sunday, November 20, 2005

Periorbital cellulitis

Alternative names

Preseptal cellulitis

Definition

Periorbital cellulitis is an infection of the tissues surrounding the eye. It can be the result of minor trauma to the area around the eye, or it may be the extension of another site of infection, such as sinusitis.

There is generally redness and swelling of the eyelid and the surrounding area, but unlike orbital cellulitis (a more extensive infection involving deeper tissue), periorbital cellulitis does not cause protrusion of the eyeball (proptosis) or limit its movements. Periorbital cellulitis is most common in children under six years of age.

However, periorbital cellulitis may progress to orbital cellulitis or meningitis if untreated. It is important to consult a physician immediately if you think that you or your child may have periorbital cellulitis.

Update Date: 11/4/2003
Updated by: John Goldenring, M.D., MPH, Department of Pediatrics, Children's Hospital, San Diego, CA. Review provided by VeriMed Healthcare Network

Medline Plus

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PRESEPTAL AND ORBITAL CELLULITIS IN CHILDHOOD: RESPONSE TO INTRAVENOUS ANTIBIOTICS

DURÁN-GIMÉNEZ-RICO MC, BOTO-DE-LOS-BUEIS A, ALBERTO MJ, GONZÁLEZ-IGLESIAS MJ, GABARRÓN-HERMOSILLA MI, ABELAIRAS-GÓMEZ J

ABSTRACT

Purpose:

To evaluate retrospectively the response of preseptal and orbital cellulitis in children to empiric antibiotic treatment.

Method:

We included nine patients (five male and four female) admitted to our hospital between October 2002 and October 2003 because of preseptal or orbital cellulitis.

Results:

Four patients (44.4%) responded to empiric antibiotic treatment (R); five (55.5%) did not respond (NR) and required a second antibiotic to resolve the infection. The presence of an upper respiratory infection was the most common associated disease in both groups, R and NR. However we also found two cases of acute dacryocystitis in the NR.

Four patients (44.4%) were treated with cefotaxime intravenously with the infection resolving in three of these. Five patients (55.6%) were treated with cefuroxime intravenously as first empiric option, however only one patient responded.

Conclusions:

We found a high prevalence of acute dacryocystitis as a potential cause of the cellulitis. Children with preseptal and orbital cellulitis responded better to cefotaxime than to cefuroxime. The presence of acute dacryocystitis was associated with a lack of response to cefuroxime (Arch Soc Esp Oftalmol 2005; 80: 511-516).

Key words:

Cellulitis, orbital, childhood, treatment, antibiotics, dacryocystitis.

Pub Med

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Periorbital Cellulitis

Cellulitis is an infection of soft tissues (like fat and muscle tissue). It can occur in any soft tissue, anywhere in the body.

Periorbital cellulitis is an infection of the soft tissues around the eye. (The orbit is the eye socket itself.) It is usually caused by an infection spreading from the membrane covering the outer part of the eye -- conjunctivitis (pink eye) (the eyeball itself is rarely the site of an infection) -- or from the nose and throat (a bacterial infection of the nose or the sinuses; the latter is called sinusitis).

Usually a child with periorbital cellulitis starts out with a sinusitis or a pink eye. And usually the sinusitis or pink eye doesn't spread beyond the sinuses or the outside of the eyes. However, if you see redness or (especially) swelling around the eye (which may or may not also include the eyelids), then periorbital cellulitis is likely beginning.

There are actually two different kinds of periorbital cellulitis, depending on exactly where the infected soft tissues are. Preseptal cellulitis involves the eyelids and/or the soft tissues around the eyes, but not the eyeball or anything else in the orbit (like the muscles that move the eye so you can keep them fixed on something you're looking at). Although the infection can spread to other parts of the face, the orbital septum (a membrane that separates the orbit from the soft tissues of the face) will help keep the orbit itself from being infected. Preseptal periorbital cellulitis is less serious, since it does not affect the eye and socket, but it can spread to the orbit. It is seen often in small children (usually under 5 years; I recently had a 1-month-old baby in the hospital for it). Several different bacteria can be responsible, including Haemophilus influenzae (which all children should be immunized against by age 2 at the latest). Although some milder cases of periorbital cellulitis can be treated at home with oral antibiotics, I almost always start treatment in the hospital with IV antibiotics, and send children home on oral medicines when they have improved. I always draw blood cultures before starting these children on antibiotics: even though the cultures rarely show bacteria, if there are bacteria in the culture the lab will be able to tell me what the best antibiotic is for that child.

The main reason I admit children with all but the mildest cases of periorbital cellulitis is to make sure that they are not developing orbital cellulitis -- infection of the soft tissues in the eye socket. Usually this involves the muscles of the eye, and the fatty tissue surrounding the eyeball which cushions the eyeball and helps it move easily. A child with orbital cellulitis usually has trouble moving the eyes, pain on trying to move the eyes, and trouble seeing (like double vision, because she can't move the eyes easily enough to keep both eyes fixed on one object. In more severe cases, the swelling in the orbit may be so bad that the eye is actually pushed part-way out of the socket. Although it is difficult for the eye itself to be infected, it can happen with an orbital cellulitis, and a doctor looking at the eye with an ophthalmoscope may see swelling inside the eyeball, especially at the "optic disc" (the spot on the retina where the nerves and blood vessels enter the eye). To be sure that the orbit is or is not infected, you usually have to do a CAT scan of the head: this shows swelling in the eye socket if it is there. Besides the possible damage to the eye itself, another big danger of orbital cellulitis is that the infection may spread along the eye's nerves and blood vessels to the brain and its surroundings, producing meningitis.

Since it is so dangerous, orbital cellulitis, even if only suspected, needs to be treated in the hospital with IV antibiotics.

Dr. Reddy's Pediatric Office on the Web

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Lymphedema People

Treatment Failure in Emrgency Department Patients with Cellulitis

By: Murray, Heather; Stiell, Ian; Wells, George. CJEM: The Journal of the Canadian Association of Emergency Physicians, Jul2005, Vol. 7 Issue 4, p228-234, 7p

Abstract (English):

Objective:

To identify the rate of treatment failure in emergency department patients with cellulitis.

Methods:

This prospective observational convenience study enrolled adult patients with uncomplicated cellulitis. Physicians performed a standardized assessment prior to treatment To calculate the interrater reliability of the assessment, duplicate data collection forms were completed on a small subsample of patients. Treatment failure was defined as the occurrence of any one of the following events after the initial emergency department visit: incision and drainage of abscess; change in antibiotics (not due to allergy/intolerance); specialist consultation; or, hospital admission.

Comparison of means and proportions between the 2 groups was performed with univariate associations, using parametric or non-parametric tests where appropriate. Results: Seventy-five patients were enrolled; 57% were male, the mean age was 48 (standard deviation 19), 71(95%) patients had extremity cellulitis and 10 (13%) had abscess with cellulitis. Fourteen episodes (18.7%, 95% confidence interval [Cl] 11 %-28%) were classified as treatment failures, with an oral antibiotic failure rate of 6.8% (95% Cl 2%-22%) and an emergency department-based intravenous antibiotic failure rate of 26.1% (95% Cl 16%-40%). Patients with treatment failure were older (mean age 59 yr v. 46 yr, p = 0.02) and more likely to have been taking oral antibiotics at enrolment (50% v. 16.4%, p = 0.01). Patients with a larger surface area of infection were also more likely to fail treatment (465.1 cm² v. 101.5 cm², p <>

Interrater agreement was high for the presence of fever (kappa 1.0) and the size of surface area of infection (intraclass correlation coefficient 0.98), but low for assessments of both severity (kappa 0.35) and need for admission (kappa 0.46).

Conclusions:

The treatment of cellulitis with daily emergency department-based intravenous antibiotics has a failure rate of more than 25% in our centre. Cellulitis patients with a larger surface area of infection and previous (failed) oral therapy are more like to fail treatment. Further research should focus on defining eligibility for treatment with emergency department-based intravenous antibiotics.

Outcome measures

The primary outcome was the rate of treatment failure.
There are currently no validated definitions of treatment
failure for cellulitis in the published literature. We devised
an evidence-based definition relying on expert opinion and
on our own observation of treatment patterns in this
centre.'"'"" Patients were labelled treatment failures if they
required any of the following: specialist consultation, hospital
admission, a change in antibiotics or a surgical procedure
(e.g., incision and debridgement). A change in antibiotics
was defined as an "upgrade" to IV antibiotics from
oral, or a change from one IV antibiotic to another; however,
patients who required a change in antibiotics due
only to an adverse effect from their antibiotic were classified
as clinical responders if they did not have any of the
other criteria listed under treatment failure.

Patient follow-up

Study personnel attempted telephone contact of all enrolled
patients 1 week after discharge to ensure that their
infection had continued to resolve as expected. Patients
without complete resolution of their symptoms or who reported
a worsening in symptoms were asked to return to
the ED for a re-evaluation. The hospital medical records of
all study patients not contacted were reviewed 1 month after
their final visit to ensure that they had not had further
ED visits for re-evaluation of their infection.

Data analysis

Univariate associations between historical features, co-existent
illness, clinical characteristics and the primary outcome
of treatment failure were calculated using SPSS.
Proportions were compared using chi-squared and Eisher's
exact tests, and the means of continuous variables were
compared using Student's r tests and Mann-Whitney U
tests where appropriate.

The reliability of the selected cellulitis measurements
was evaluated on the sample of patients who had duplicate
data forms completed. The percentage agreement for each
variable was calculated. Kappa statistics were calculated
for dichotomous variables and intraclass correlation coefficients
(one way random effects model) for the continuous

variables.

Results

During the 8-month study period 86 patients were enrolled.
Eleven patients were subsequently excluded from analysis
because they had infections deemed ineligible (1 bite
wound, 3 post-op. 2 diabetic foot infections) or were referred
or admitted at the first ED visit (5 patients), leaving a
study population of 75 patients. A summary of treatment decisions
and patient outcomes is displayed in a flow chart in
Figure 1 (see page 230). Of the 70 patients ultimately discharged
from ED care, 48 (68.6%) were successfully contacted
and reported their infection to be completely resolved
or significantly improved. None of the remaining 22 patients
returned to either centre within 1 month of their treatment,
and thus these patients were classified as clinical responders.

The demographic data and comorbidities of the 75 study
patients are shown in Table 1. The historical features and
physical exam findings are summarized in Table 1. Of
note, 18 patients (24%) in the study group reported a previous
episode of cellulitis. the majority occurring in
the same anatomic location.

Of the 75 study patients, 29 (38.6%) were treated
initially with oral antibiotics and 46 (61.4%) were
given ED-based IV antibiotics. Fourteen patients
met the definition for treatment failure, for an overall
failure rate of 18.7% (95% CI ll%-28%).

There were 2 treatment failures in the oral antibiotic
group (6.8%, 95% CI 2%-22%). compared
with 12 of the 46 patients (26.1%, 95% CI
16%^0%) in the IV group. Table 2 describes the
type and timing of the treatment failure outcome.

Nineteen patients had duplicate data collection
forms completed, by a total of 11 different physicians.
Calculated measures of agreement for these
data are summarized in Table 3. The agreement
between physicians on the presence of fever, the
presence of systemic symptoms and the likelihood
of abscess were high, with kappas of 1.0 and 0.73,
respectively. There was poor agreement for both
physician assessment of severity (kappa 0.35) and
teristics of ihe treatment failure group compared with those
patients who re.sponded successfully. Older patients were
significantly more likely to fail treatment. Other characteristics
associated with failure included prior antibiotic treatment
and the initial size of the infection, as measured both
by the single largest diameter and the area of erythema.

Discussion

Our high rate of treatment failure is concerning, and reinforces
the need for further evaluation of this therapy. Iden-
tifying patients who are likely to fail treatment is an important
step in evaluating eligibility for any treatment plan.

Patients who are older or have peripheral vascular disease
seem more likely to fail treatment, as do patients previously
treated with oral antibiotics for cellulitis or who have
a larger size of infection at first ED presentation. These
findings should be verified in future studies. The higher
rate of treatment failure seen in our ED-based IV treatment
group was possibly due to the increased severity of those
infections. We may be underestimating which patients seen
in the ED require hospital admission. Currently there are
no guidelines defining the indications for either IV
therapy or hospital admission. Further study into
the indicators of infection severity and clarification
of which infections require inpatient treatment
is needed.

Published estimates of treatment failure in cellulitis
vary. The failure rate in a retrospective chart review''
of 170 patients treated with ED-based IV antibiotics
in our centre over a different I -year period
— using the same criteria for treatment failure —
was 27.4%. A 1999 abstract comparing a protocol of
ED-based IV antibiotics versus a single dose of IV
antibiotics followed by oral therapy found a failure
rate of 32.4%.''' Another group reported a treatment
failure rate of only 12% in 346 patients when looking
at the etTicacy of ED-based IV therapy using cefazolin
and probenecid." A Canadian study examined
the treatment strategies in 5 Canadian urban
centres and found an overall treatment failure rate of
12% in 416 patients treated for cellulitis over a Iyear
period.-

This study (which included both oral
and IV antibiotic regimens) noted more than 25 different
initial antibiotic choices and dose regimens in
the study patients, and did not pubhsh the IV treatment
failure rate. An ED-based trial comparing IV
cefazolin and probenecid with IV ceftriaxone reported
similar failure rates in both arms (7% v. 8%).
However the cause of cellulitis in the majority of the
trial population was IV drug use and, due to concerns
about follow-up, all patients in both arms were
also treated with oral antibiotics throughout the
trial.' Another clinical trial comparing home-ba.sed
IV cefazolin plus probenecid with IV ceftriaxone reported
a treatment failure rate of 14% in the cefazolin
arm and 4% in the ceftriaxone arm.' In that
study, a large proportion of patients had an "indeterminate
clinical outcome" in both arms. Ifthese indeterminate
patients had been considered treatment
failures, then failure rates would have been 32.5% in
the cefazolin group and 30% in the ceftriaxone group.

Our study is the first to examine the interrater agreement
of the characteristics of celluUtis. The agreement between
physicians on these characteristics is very strong when objective
measurements are used (such as fever or diameter
of erythema), and the agreement appears to be poor to
moderate when physicians are asked for a subjective clinical
impression (such as an impression of severity). This
finding demonstrates the need to record the objective manifestations
of these infections and to clarify the features of
severity and the admission requirements.

Limitations

Our study has some important limitations. Due to the
availability of the research nurses, patients were not enrolled
during night shifts and weekends. Two-thirds of our
patients were treated with IV antibiotics, suggesting that
many patients treated with oral antibiotics were not enrolled.
Enrolment was slower than expected, and even with
extension of the study time frame, we still did not meet our
target of 100 patients. There is the potential for selection
bias and, consequently, an overestimation of the treatment
failure rates. Our small sample size was not adequate for a
multivariate analysis. Some of the features that appeared to
be associated with treatment failure did not reach statistical
significance in our univariate analysis, and this may also
be due to the small sample size.

Despite these limitations, this is the first ED study to
prospectively identify specific patient and infection characteristics.
Our definition for treatment failure was also
prospectively defined and implemented after an extensive
review of the cellulitis literature. There have not been any
previous attempts to examine the interrater reliability of
the features of cellulitis. and although our sample size was
small, we have been able to show disagreement between
physicians on many of the more subjective features of cellulitis.
These fmdings will be used to assist with the design
of future research to establish which patients should be eligible
and will benefit most from treatment with ED-based IV antibiotics.

Conclusions

The treatment of cellulitis with daily ED-based IV antibiotics
has a treatment failure rate of more than 25% in our
centre. A clinical trial of this practice is needed to determine
which patients may benefit from more intensive IV
therapy, as is possible with admission. Older patients and
patients with previous (failed) oral therapy and those infections
over a larger area are more likely to fail ED treatment
for cellulitis. Physicians show high interrater reliability for
the objective findings of skin and soft-tissue infections
(such as fever and estimated size) but poor interrater reliability
for subjective decision (such as infection severity and
need for hospital admission). Further research should also
be focused on identifying infection characteristics for clinical
decision-making that are reliable and reproducible.

[ABSTRACT FROM AUTHOR]

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Lymphedema People



Complications of Cellulitis

There are many complications that can arise from cellulitis, even treated episodes. These complications can include sepsis, septicemia, bacteremia, and gangrene.

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Sepsis

Sepsis is a life threatening infection wherein the bloodstream has been invaded by bacteria. As a result the bacteria spreads rapidly throughout the body. Untreated sepsis or late treated sepsis will result in septicemia and death.Determination of sepsis and identification of the bacterium is done through blood cultures.

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Sepsis

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Sepsis B

Bill Harrison, MD

Sepsis is a severe infection in the body and bloodstream that can lead to shock, a reaction caused by lack of blood flow in the body

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WHAT IS SEPSIS?

Sepsis can be defined as the body’s response to an infection. An infection is caused by microorganisms or "germs" (usually bacteria) invading the body, and can be limited to a particular body region (e.g., a tooth abscess) or can be widespread in the bloodstream (often called "septicemia" or "blood poisoning").

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Sepsis Pathophysiology and Treatment

Medscape/WebMD

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Septicemia

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Septicemia Images

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Septicemia

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Septicemia

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Septicemia

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Septic shock

Septic shock is a form of physiological shock resulting from septicemia (bacteria in the blood). Fever, rapid heart beat, fast breathing and confusion may also occur. Septic shock generally follows the same sign of severe infection and blood culture are critical to the correct diagnosis and treatment. Untreated or incorrectly treated septic shock can result in death.

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Shock, Septic

Last Updated: July 25, 2002Synonyms and related keywords: bacteremia, sepsis, systemic inflammatory response syndromeAuthor: J Stephan Stapczynski, MD, Chair, Professor, Department of Emergency Medicine, University of Kentucky Chandler Medical Center

http://www.emedicine.com/EMERG/topic533.htm

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Septic shock

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Optimal management of septic shock

Stephen J. Fitch, MD; James R. Gossage, MDVOL 111 / NO 3 / MARCH 2002 / POSTGRADUATE MEDICINE

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Treating Septic shockPatrick Neligan - University of Pennsylvania

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Septic shock

By Adam Brochert, MD

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Bacteremia

Simply defined as the presence of bacteria in the blood. Bacteremia is diagnosed by rowing organism from a blood sample and is treated with antibiotics. See also septicemia

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Bacteremia

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Bactermia

Last Updated: January 24, 2003Synonyms and related keywords: bacteriemia, fever, fever without a source, FWS, occult bacteremia, bloodstream infection, serious bacterial infection, SBIAuthor: Brian J Holland, MD, Staff Physician, Department of Pediatrics, Tripler Army Medical Center

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Bacteremia

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Quality Standard for the Treatment of Bacteremia

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Gangrene

Gangrene is a serious possible complication from infections that can result in either loss of limb or life. It is the necrosis or death of tissue as a result of loss of blood supply or bacterial invasion.While gangrene most often involves the limbs, it can occur anywherethat an extensive infection has taken place.It can have a foul or offensive odor, spread rapidly, and may result in death in a few days. In all types of gangrene, surgery is required to remove the dead tissue.

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Dry Gangrene

Dry gangrene is a problem associated with diabetes mellitus that has lead to a thickening and hardening of the walls of the arteries (arteriosclerosis) in which the affected limb becomes cold, dry, shriveled and may eventually turn black.

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Moist Gangrene

Moist gangrene may follow a crushing or traumatic injury wherein there is a blockage of blood flow by a clot, embolism, tight bandages or tourniquet.

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Gangrene

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Lymphedema People

Friday, November 18, 2005

Antibiotic Treatment for Cellulitis at Home

Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital

Paul Corwin, senior lecturer1, Les Toop, professor1, Graham McGeoch, general practitioner2, Martin Than, consultant in emergency medicine3, Simon Wynn-Thomas, medical director community care2, J Elisabeth Wells, biostatistician1, Robin Dawson, research fellow1, Paul Abernethy, manager community care2, Alan Pithie, consultant physician of infectious diseases3, Stephen Chambers, clinical director of infectious diseases3, Lynn Fletcher, biostatistician1, Dee Richards, senior lecturer1

Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, PO Box 4345, Christchurch, New Zealand, 2 Pegasus Health PO Box 741, Christchurch, New Zealand, 3 Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand
Correspondence to P Corwin
paul.corwin@chmeds.ac.nz

Abstract

Objectives To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital.
Design Prospective randomised controlled trial.
Setting Christchurch, New Zealand.


Participants 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital.

Main outcome measures Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded.

Results

The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home.

Conclusions

Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment.

Introduction

Cellulitis, an acute bacterial infection of the skin and subcutaneous tissues, is a common condition that often requires treatment with intravenously administered antibiotics. This treatment is delivered in hospital in most countries, but intravenous treatment at home is used increasingly, particularly in the United States where insurance companies are reluctant to fund more expensive hospital treatment.
1 Many retrospective reports exist on the outcomes of intravenous antibiotic treatment for cellulitis at home, which indicate that this is a safe alternative to inpatient treatment in hospital.2-6 Only one small prospective randomised trial has been reported that compared treatment at home with treatment in hospital, which included 37 patients with cellulitis.7 This study concluded that home treatment for conditions such as cellulitis and pneumonia was safe and associated with fewer adverse complications in elderly patients.

In the three years before this study, Christchurch Hospital admitted more than 500 patients each year for inpatient treatment of cellulitis. In the year before this study 1.7% of all adult medical admissions and 0.7% of surgical admissions were patients with the principal diagnosis of cellulitis. In 2001 Pegasus Health, an independent practitioners' association of 230 general practitioners in Christchurch, started a community care programme that delivered medical and nursing care to patients who would otherwise require hospital admission. The advent of this community care service initiated from general practice provided an ideal opportunity to mount a prospective, randomised trial with the objectives of comparing the safety, efficacy, and acceptability of home treatment with hospital treatment of cellulitis requiring intravenous antibiotics. Our hypothesis was that home treatment of cellulitis with intravenous antibiotics was as effective as hospital treatment and more acceptable to patients.

Methods


No clearcut guidelines exist for when cellulitis requires treatment with intravenous antibiotic other than in case oral antibiotics fail. In this study the decision whether intravenous antibiotics were required was left to the attending doctors in the emergency department who assessed the patient.

No validated objective measures seem to exist of when cellulitis is improving or when patients can be switched from intravenous to oral antibiotics. We chose as our primary outcome measure the time to when the cellulitis failed to advance. This outcome has been used in one previous study.
8 Other outcomes recorded included the total numbers of days when patients received intravenous antibiotics and oral antibiotics, and calendar days in hospital or looked after by the home care team. The decision when to switch patients from intravenous to oral antibiotics was left entirely to the attending doctor in the hospital or home. We recorded patients' transfers from home to hospital and the reasons for transfer. We kept a record of all serious complications experienced by patients. We used questionnaires to assess patients' level of functioning and pain as well as satisfaction with their care.

Christchurch Hospital serves the whole metropolitan area of Christchurch (population in 2001 was 318 000), and all acutely referred patients are treated there. We informed all general practitioners in Christchurch and emergency department staff at Christchurch Hospital of this trial before it started.

Protocol

We recruited participants from patients with cellulitis who were attending Christchurch Hospital's emergency department, whether self referred or referred by their general practitioner or a general practitioner after hours. Patients who were considered to require intravenous antibiotic treatment for cellulitis by the emergency doctor and who met the eligibility criteria received an invitation to take part in the trial.

Patients were eligible for the trial if they had clinical signs of cellulitis, were assessed as requiring intravenous antibiotic treatment because of severity of cellulitis or failure of oral antibiotic treatment, were 16 years or older and mentally competent to give informed consent, had a telephone at home and a caregiver nearby, and were currently resident in the Christchurch metropolitan area.

Exclusion criteria were pregnancy; treatment with intravenous antibiotics for cellulitis of the same site in the preceding month; two or more signs of systemic sepsis (temperature > 38°C or <> 90/min, respiratory rate > 20/min); and a blood count showing a white cell count above 12x109/l or less than 4x109/l and more than 0.1x109/l immature neutrophils.
9

Other possible exclusion criteria were signs of severe cellulitis or serious comorbidities such as cellulitis of the face, hands, or over joints; presence of tissue necrosis, severe lymphangitis, blistering, or a very large affected area; comorbidities such as immunosupression, peripheral vascular disease, obesity, alcoholism, or severe diabetes. The more of these relative exclusion criteria were present the more hospital admission was recommended.

Routine blood tests were not required, and the criteria for exclusion were deliberately kept flexible as ultimately the staff in the emergency department often had to make a subjective judgment about the suitability of a patient for entry into the trial. This decision was made independently from the investigators conducting the trial, and junior staff in the emergency department always conferred with consultant staff in making the decision to enrol patients in the trial. Between the hours of 8.00 and 22.00, a member of the study team visited the patient in the emergency department and, after the patient had read the trial information and consent sheets, obtained informed consent. Outside this time patients received an initial dose of intravenous cephazolin and were looked after in the emergency department's observation ward until the following morning when study staff obtained informed consent.

Assignment

Once a patient had given consent he or she was assigned a unique study number, and allocation to home or hospital treatment was determined by phoning an off-site coordinator who kept the randomisation list and assigned each study number to either home or hospital treatment. The randomisation list was produced by SAS code from the SAS statistical package (SAS Institute, Cary, NC 27513-2414, USA) using randomly allocated block sizes with a maximum of 20. In each block, equal allocations were made to the two arms of the trial.

The study team collected information on the participants in the emergency department, including demographic information (sex, date of birth, ethnicity, address, occupation, community card status); details of any current or recent use of antibiotics, the location of cellulitis; and the presence of any skin necrosis, lymphangitis, blistering, or ulceration.

The researcher drew an indelible line with a marker pen around the peripheral margin of the cellulitis and dated this for comparison on following days.

Before leaving the emergency department, every participant received his or her first intravenous dose of 2 g of cephazolin. If renal impairment was suspected or known, the creatinine concentration was measured and the dose adjusted. Those participants randomly allocated to hospital treatment were then admitted to a hospital ward under the care of the on-call medical team who managed the subsequent clinical treatment, including the choice of ongoing intravenous antibiotic. Participants allocated to hospital treatment were visited each day by the study team to record clinical progress.

Patients who were randomly allocated to community treatment continued with 2 g of intravenous cephazolin (modified in renal impairment) twice daily. Their own general practitioner or a general practitioner from the community care team visited them daily for medical review, and community care nursing staff attended twice daily to monitor the cellulitis and administer intravenous antibiotics. Research staff reviewed community and hospital participant clinical records in all cases. This review included duration of stay, details of antibiotic treatment, and complications.

At entry into the trial and at days 3 and 6, we administered a questionnaire modified from the short form 36 (SF-36) instrument, which focused on functional and physical aspects of health.
10 At trial entry we asked patients to respond about their health before the infection, whereas at days 3 and 6, we asked them to respond about their health in the previous 24 hours. We administered questionnaires face to face at trial entry and when participants remained in hospital or by telephone if the patients had left hospital. Patients completed a patient satisfaction questionnaire four weeks after entry into the trial.

Statistical methods


he study was designed to have 200 participants, 100 in each arm. With power of 80% and 2 = 0.05, a moderate difference of 0.40 standard deviations was detectable between the two arms for the primary outcome of no advancement of cellulitis. The clinician researchers thought that a difference of up to two days would be acceptable. The standard deviation in each group was not known, but as long as it was less than five days the study had adequate power. We used survival analysis for the main clinical outcomes and, to compare the groups, 2 tests for contingency tables and t tests for continuous variables. We carried out our analyses in SAS, version 8.02 (SAS Institute, Cary, NC 27513-2414, USA).

Results

The trial ran from July 2002 until June 2003. We randomised 200 patients meeting the inclusion criteria to receive treatment either at home or in hospital. At the end of the trial we excluded six patients, three from each trial arm (owing to the randomisation process 101 patients were randomised initially to home treatment and 99 to hospital treatment) from the final analysis. Three of these patients had their diagnosis changed after trial entry to dermatitis, erythema nodosum, and a ruptured Baker's cyst. One patient was lost to follow up, one withdrew consent, and one home patient was allergic to cephazolin and had to be withdrawn from the trial as we did not have available an alternative intravenous antibiotic for home treatment at that time.
Figure 1 shows the flow of participants through the trial.

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Fig 1 Flow of participants through the trial


Table 1 shows the distribution of key variables between the two care groups. The two groups were similar except that the hospital care group were younger than the home care group (48 years v 55 years, respectively) and had a lower proportion of users of community service cards (37% v 53%). (Community service cards entitle holders to subsidised general practice, and they are issued on the basis of low income.) All patients treated at home received intravenous cephazolin. Fifty five per cent (53) of the hospital patients received cephazolin as well, but 29% (28) of the hospital patients received flucloxacillin and the remaining hospital patients various other antibiotics.

View this table:[in this window][in a new window]
Table 1 Characteristics of patients at baseline. Values are percentages (numbers) of patients unless otherwise indicated


Clinical outcomes

The primary clinical outcome was days to no advancement of cellulitis. The mean was 1.50 (SD 0.11) days for the home treatment group and 1.49 (0.10) days for the hospital group (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). Because of the marked skew in all clinical outcomes we also compared the treatment arms by survival analysis, as shown in figure 2 and table 2. We found no significant differences on any of these outcomes, neither for simple comparisons of the two types of care nor when controlling for age, sex, location of cellulitis, and prior use of antibiotics.

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Fig 2 Kaplan-Meier plots for primary and secondary outcomes


View this table:
[in this window][in a new window]
Table 2 Home care versus hospital care: hazard ratios with 95% confidence intervals


Patients' functional outcomes

We used independent t tests to analyse modified SF-36 questionnaires administered at baseline and at days 3 and 6 and found no significant differences in levels of physical functioning or pain between the two treatment arms (see appendix and table A on bmj.com))

Patients' satisfaction with site of treatment

Table 3 summarises the patients' level of satisfaction after one week of oral antibiotic treatment with the care they received as well as their theoretical preference for location of care. Most patients in both treatment arms were satisfied with the care they received. However, only one in 20 of the community arm would prefer hospital treatment, whereas one in three of those receiving hospital care felt that home care was preferable. These results strongly imply that home care is the preferred treatment choice of cellulitis patients, particularly those who have experienced community care.

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Table 3 Patients' satisfaction with care after one week on oral antibiotics

Complications

Eleven patients (12%) randomised to home treatment required transfer to hospital. Four did not show satisfactory clinical improvement; one required surgical drainage under general anaesthetic; and two needed insertion of peripherally inserted central catheters. One patient was admitted because of an ischaemic toe, one because of a severe rash, one because of nausea and vomiting after starting oral antibiotics, and one because she was not coping at home.

Three hospital patients (3%) required readmission within one month of discharge for further treatment of their cellulitis. Two hospital patients received peripherally inserted central catheters while in hospital, and two patients required surgical drainage under general or spinal anaesthetic.

Discussion

Many patients with cellulitis thought to require intravenous antibiotics can safely be treated at home under a primary care home treatment programme. The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home.

Strengths and weaknesses of this study

We conducted a large randomised controlled trial of home treatment compared with hospital treatment for cellulitis requiring intravenous antibiotics. The clinical outcomes we have reported of failure of cellulitis margin to advance, time on intravenous antibiotics, and time spent in hospital or in home care are practical clinical outcomes that could be used in further reports of cellulitis treatment. General practitioners could not obtain home intravenous antibiotic treatment for their patients in any other way during this trial, which ensured that we had good "capture" of patients suitable for home intravenous treatment. We were not able to keep a record of cellulitis patients who declined to be randomised into this trial as emergency doctors notified trial staff only of cellulitis patients thought to be suitable and willing to enter this study. Only one trial patient withdrew consent, ensuring a high participation rate among randomised patients.

Comparison with other studies

Our study can be compared with other reports of intravenous treatment for cellulitis at home. A study from Australia of 100 patients being treated for a variety of conditions generally requiring hospital treatment (cellulitis, pneumonia, pyelonephritis, etc) randomised half to home treatment.
7 This study included 37 patients with cellulitis, but the outcomes for this group of patients was not described separately. This study found that patients treated in hospital had higher rates of confusion and urinary and bowel complications. Overall, the patients treated at home spent 10.1 days in the programme, whereas the hospital patients stayed in hospital 7.4 days. Three other studies from Australia have described the results of intravenous treatment of cellulitis at home.3 4 11 Patients in these studies all needed 5.5-6.5 days of intravenous treatment at home. In these studies, 5.8-7.8% of patients treated at home required transfer to hospital. These figures are broadly in keeping with our results, but patients in both of our treatment arms were kept on intravenous treatment for a shorter duration than in the above studies. Other reports of outpatient treatment with parenteral antibiotics exist, but they do not give sufficient detail on the outcomes of cellulitis treatment to compare usefully with this study.
A US based registry for outcomes of outpatient treatment with parenteral antibiotics collects information from 24 participating sites. This registry has recorded a 12.6% rate of transfer to hospital for more than 5000 patients treated outside hospital with intravenous antibiotics.
12

Other studies may have had a different threshold of severity of cellulitis in assessing the need for intravenous treatment and for when hospital admission should be considered mandatory. Almost 75% of our patients started receiving intravenous antibiotics after oral antibiotics had failed. This is a much higher proportion than reported in other studies and indicates that our threshold for giving intravenous antibiotics was appropriate.
2 4 7

The high degree of satisfaction with home treatment we found has been reported from other studies of "hospital at home" programmes.
13 14

Two studies from Australia and one from the United States have compared the costs of treatment for cellulitis and other acute medical conditions at home and in hospital.
2 6 15

These studies found that home treatment was about half as costly as hospital treatment.


Other reports of home intravenous treatment have been hospital outreach programmes, and this study shows that a programme initiated and delivered from general practice can achieve satisfactory clinical outcomes. The successful operation of this programme was dependent on a small group of trained nurses and general practitioners who were able to offer support to their colleagues in delivering treatment with intravenous antibiotics.

What is already known on this subject

Intravenous antibiotic treatment of cellulitis can be delivered in the home
The safety, efficacy, and costs of home treatment compared with hospital treatment have not been studied extensively


What this study adds

Intravenous antibiotic treatment can be delivered safely and effectively in patients' homes

Patients prefer home treatment


This home based treatment programme was initiated and delivered from primary care rather than a hospital outreach programme

Meaning of this study

Patients in the two treatment arms were comparable. These findings should be generalisable to other settings with comparable systems of healthcare delivery. It must be noted that only about a third of patients requiring intravenous antibiotics for cellulitis were considered suitable for home treatment during the study period. In total 558 adult patients with a primary diagnosis of cellulitis (including those in this study who were randomised to hospital treatment) were admitted to Christchurch Hospital during the study period. Many patients with cellulitis will require admission to hospital because of their frailty, comorbidities, home situations, or the severity of their cellulitis. Patients with cellulitis require careful and daily monitoring as some will require transfer to hospital. It is possible that more patients with cellulitis could have been considered for home treatment. Patients clearly much prefer home treatment for cellulitis.

Unanswered questions and future research

Having twice daily visits from the nurse increased the costs of home treatment in this study. A report of home treatment using once daily intravenous antibiotics and nurse visits has shown that this is a safe option.
11 We considered that only about one third of patients requiring intravenous antibiotics for cellulitis were suitable for home treatment, and it is possible that a higher proportion of cellulitis patients could have been safely treated at home. This study was too small to study predictors of failure of home intravenous antibiotic treatment.

An appendix and table showing mean scores on the SF-36 with standard deviations for days 3 and 6 are on bmj.com

We thank Pegasus Health and their extended care nurses and the staff of the emergency department of Christchurch Hospital and Felicity Beats, Margaret Sutherland, and Alison Parsons.

Contributors: PC, LT, SC, AP, and GM conceived the study. PC wrote the protocol and supervised the trial and interpretation and drafted the paper with contributions from the other authors and is guarantor. EW worked on the design of the study and supervised the data analysis and LF provided statistical advice and performed the data analysis.

Funding: This study was supported by Pegasus Health. RD was a research fellow funded by Pegasus Health. The guarantor accepts full responsibility for the conduct of the study, had full access to the data and controlled the decision to publish and received no funding from Pegasus Health.

Competing interests: None declared.
Ethical approval: Canterbury Ethics Committee.

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