Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the optimal outpatient treatment strategy of
uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the
prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA)
is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of
SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive
Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication),
clindamycin, or cephalexin or some combination of these. The study population will include
2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban
Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected
wound, and cellulitis will start on the day of enrollment. Participants may be involved in
study related procedures for about 9 weeks.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)