Trimethoprim-Sulfamethoxazole or Doxycycline for Skin and Soft Tissue Infections

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become more prevalent than infections with β-lactam susceptible bacteria. This has necessitated altered empiric antimicrobial therapy of SSTI to cover MRSA.

Objective: To evaluate empiric therapy with trimethoprim-sulfamethoxazole or doxycycline for outpatient SSTI in an area of high MRSA prevalence.

Design: Randomized, prospective, open-label investigation. Setting: Emergency Department of Parkland Hospital in Dallas, Texas. Patients: Adults with SSTI. Intervention: Empiric oral therapy with trimethoprim-sulfamethoxazole (160 mg/800 mg, twice daily) or doxycycline (100 mg, twice daily).

Measurement: The primary endpoint was clinical failure defined as hospitalization or change in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Doxycycline; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Outpatient treatment of SSTI abscesses, requiring wound packing after incision and drainage but not requiring hospitalization.

• Adults (≥ 18 years old) who were willing and able to provide informed consent.

• Able to return for follow-up at 2 to 5 days after enrollment and being accessible by telephone for follow-up assessment at 10 to 14 days and 28 to 35 days after enrollment.

Exclusion Criteria:

• Exclusion criteria excluded patients with contraindications or history of hypersensitivity reaction to any of the study treatment regimens, an infected prosthesis or device, concomitant bacteremia or deep infections (e.g. osteomyelitis, necrotizing fasciitis, endocarditis), diabetic foot infections, known immunodeficiency, pregnant or breastfeeding, requirement of additional antimicrobial agents, and those who did not obtain assigned antibiotics.