Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management
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|ClinicalTrials.gov Identifier: NCT00679302|
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : April 29, 2014
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases, Infectious||Drug: Trimethoprim-sulfamethoxazole Drug: Placebo group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||May 2008|
Placebo Comparator: placebo group
Maalox and bitter mixture
Drug: Placebo group
Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
Other Name: Maalox (with simethicone and bitter mixture)
Active Comparator: antibiotic group
Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.
Other Name: Septra
- Skin Abscess Resolution [ Time Frame: 10-14 days ]
- New Lesion Development and Spread of Skin Abscesses (on Subject) [ Time Frame: 10-14 days and 3 month ]The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679302
|United States, Missouri|
|Cardinal Glennon Children's Medical Center|
|Saint Louis, Missouri, United States, 63104|
|Study Director:||John Peter, MD||St. Louis University|