Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management
A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics
Sponsor: St. Louis University
This PHASE4 trial investigates Skin Diseases, Infectious and is currently completed. St. Louis University leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.
This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
-
Sep 2025 — Present [monthly]
Completed PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE4
▶ Show 3 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE4
First recorded
Jul 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- St. Louis University
For direct contact, visit the study record on ClinicalTrials.gov .