Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

Completed · Phase 2 · Has a placebo group

Conditions studied: Staphylococcal Infection

In brief

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 outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.

Key facts

Study ID

NCT00730028

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1310

Starts

2009-04-01

Expected to finish

2015-02-01

Last updated by the study team

2016-03-17

Who can join

Age: 1 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital - Infectious Diseases — San Francisco, California, United States
• Harbor UCLA Medical Center - Medicine - Infectious Diseases — Torrance, California, United States
• Morehouse School of Medicine - Morehouse Medical Associates - Atlanta — Atlanta, Georgia, United States
• The University of Chicago - Comer Children's Hospital - Infectious Diseases — Chicago, Illinois, United States
• Washington University School of Medicine in St. Louis - Infectious Diseases — St Louis, Missouri, United States
• Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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