Status:
COMPLETED
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Staphylococcal Infection
Eligibility:
All Genders
6-85 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, \[clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)\] and wound care for the outpat...
Detailed Description
Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI) has not kept pace with the emergence of methicillin-resistant Staphylococcus aureus (MRSA) in the community...
Eligibility Criteria
Inclusion
- Age 6 months to 85 years.
- Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 7 and older.
- Willing and able to complete the study protocol, study-related activities, and visits.
- Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
- Erythema
- Swelling or induration
- Local warmth
- Purulent drainage
- Tenderness to palpation or pain
- Able to take oral antibiotic therapy, either in pill or suspension form.
Exclusion
- Hospital in-patient.
- Hospitalization within the prior 14 days.
- Residence in a long-term skilled nursing facility.
- Requirement for hospitalization for skin infection or other condition.
- Previous enrollment in this protocol.
- Participation in another clinical trial within the previous 30 days.
- Superficial skin infection only, including:
- Impetigo
- Ecthyma
- Folliculitis
- Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
- Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements.
- Systolic blood pressure \> 180 mm Hg.
- Systolic blood pressure (SBP) less than an age-specific critical value:
- Age 6 - 11 months: \< 70 mm Hg
- Age 1 to 8 years: \< 80 mm Hg
- Age 9 to 17 years: \< 90 mm Hg
- Age greater than or equal to 18 years: \< 90 mm Hg
- Heart rate less than 45 beats per minute (BPM).
- Heart rate greater than an age-specific critical value:
- Age 6 - 11 months: \> 140 BPM
- Age 1 to 8 years: \> 120 BPM
- Age 9 to 17 years: \> 120 BPM
- Age greater than or equal to 18 years: \> 120 BPM.
- Oral temperature (or equivalent rectal, tympanic membrane, axillary) less than 35.5 degrees Celsius (95.9 degrees Fahrenheit).
- Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:
- Age 6 - 11 months: \> 38.0 degrees Celsius (100.4 degrees Fahrenheit)
- Age 1 to 8 years: \> 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age 9 to 17 years: \> 38.5 degrees Celsius (101.3 degrees Fahrenheit)
- Age greater than or equal to 18 years: \> 38.5 degrees Celsius (101.3 degrees Fahrenheit).
- Documented human or witnessed animal bite in the past 30 days at the site of infection.
- Systemic antibacterial therapy with antistaphylococcal activity within the prior 14 days.
- The following concomitant medications: warfarin, phenytoin, methotrexate, rosiglitazone or sulfonylureas and systemically administered antibacterial agents with activity against staphylococci.
- Diagnosed or suspected disseminated or severe Staphylococcus aureus or group A streptococcal (GAS) infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infections.
- Infection at an anatomical skin site requiring specialized management or specialized antimicrobial therapy, including:
- Periauricular or orbital infection
- Perirectal infection
- Suspected deep space infection of the hand or foot
- Genital infection
- Mastitis
- Bursitis
- Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician).
- Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics.
- Hypersensitivity or history of allergic reaction to study drug.
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Third trimester pregnancy: pregnant women must have gestational age estimated by an objective means, e.g. ultrasound, fundal height, and women who are within 4 weeks of the third trimester of pregnancy, defined as week 27 of pregnancy, are not eligible.
- Currently breast feeding.
- Severe or morbid obesity with a body mass index (BMI) \>40 kg/m\^2.
- Complicated skin or soft tissue infection, such as:
- Catheter or catheter site infection within 30 days of placement
- Surgical site infection
- Known or suspected prosthetic device infection
- Suspected Gram-negative or anaerobic pathogen
- Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc)
- Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis
- History of underlying immunocompromising condition or immunodeficiency, for example:
- Diabetes mellitus
- Chronic renal failure, creatinine clearance \<30 ml/min
- Renal dialysis within the past 180 days
- Human immunodeficiency virus (HIV)-positive with either cluster of differentiation (CD)4 count \<200 or \<4 percent CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months
- Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease
- Other serious underlying disease, as determined by the treating physician or the investigator
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
1310 Patients enrolled
Trial Details
Trial ID
NCT00730028
Start Date
April 1 2009
End Date
February 1 2015
Last Update
March 17 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco General Hospital - Infectious Diseases
San Francisco, California, United States, 94110-3518
2
Harbor UCLA Medical Center - Medicine - Infectious Diseases
Torrance, California, United States, 90502-2006
3
Morehouse School of Medicine - Morehouse Medical Associates - Atlanta
Atlanta, Georgia, United States, 30303-2544
4
The University of Chicago - Comer Children's Hospital - Infectious Diseases
Chicago, Illinois, United States, 60637-1425