For Clinical Researchers – Treatment Study
Randomized, Double Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus aureus
The community-associated (CA) methicillin-resistant Staphylococcus aureus (MRSA) epidemic has complicated empiric antibiotic therapy of uncomplicated skin and soft tissue infections (uSSTIs). Public health authorities have issued new guidelines for the treatment of uSSTIs but recommendations are based on limited data. Few data on the efficacy of agents for CA-MRSA uSSTIs exist.
To determine the optimal management of uSSTIs in the setting of epidemic CA-MRSA in both children and adults in areas where CA-MRSA is prevalent. Primary objectives include comparing the cure rates of uSSTIs treated with clindamycin (CLINDA) with treatment with trimethoprim-sulfamethoxazole (TMP-SMX).
Non-immunocompromised patients, both children and adults, with uSSTIs. Approximately one-third of the patients will be children. The majority of patients will be recruited from the Emergency Departments of the 3 participating institutions (see "Study sites" below).
We enroll children and adults with uSSTIs into a stratified, randomized, double blind trial in which patients are randomized to either CLINDA, TMP-SMX, or placebo. We also quantify the incidence of infection recurrence and relapse.
We will randomize 786 patients with less severe purulent SSTIs 1:1:1 into CLINDA, TMP-SMX, or placebo arms (incision and drainage as relevant). We will randomize 524 patients with more severe purulent SSTIs 1:1 to CLINDA or TMP-SMX (incision and drainage as relevant).
Study medication will be dispensed at the Enrollment Visit on Day 1. Follow-up visits consist of: a Wound Check Visit on Day 3 (48 hours after enrollment); an End of Treatment (EOT) Visit on Day 12 (within 48 hours of last dose of study medication); a Test of Cure (TOC) Visit on Day 17-20 (7-10 days after the last dose of study medication); a One Month Follow-Up (OMFU) Visit on Day 40 (one month after completion of the last dose of study medication); and a Termination of Study Protocol Visit (TOSP) Visit (within 72 hours after discontinuing study medication). The primary efficacy endpoint is clinical cure at the Test of Cure (TOC) Visit. Secondary endpoints include clinical cure or clinical improvement at the End of Treatment (EOT) Visit and at the One-Month Follow-Up (OMFU) Visit.
Principal Investigators and Study Sites
Henry F. Chambers, MD, San Francisco General Hospital, University of California San Francisco
Robert S. Daum, MD, CM, University of Chicago Medical Center
Loren G. Miller, MD, MPH, Los Angeles County Harbor-UCLA Medical Center
National Institutes of Health (NIH); National Institute of Allergy and Infectious Diseases (NIAID)
For more detailed information on the Treatment Study, please the PowerPoint presentation.