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
: April 29, 2014
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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)
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Active Comparator: antibiotic group
Trimethoprim-sulfamethoxazole suspension
|
Drug: Trimethoprim-sulfamethoxazole
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
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- Skin Abscess Resolution [ Time Frame: 10-14 days ]
- New Lesion Development and Spread of Skin Abscesses [ 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.

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Ages Eligible for Study: | 3 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- non-toxic patients
- immunocompetent patients
- 3 months to 18 years old
- English-speaking patients
- skin abscesses
- not on antibiotics
Exclusion Criteria:
- toxic patients
- immunocompromising co-morbidities
- less than 3 months old or older than 18 years of age
- non-english speaking
- on antibiotics

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 | |
St Louis, Missouri, United States, 63104 |
Study Director: | John Peter, MD | St. Louis University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Myto Duong, Assistant Professor, St. Louis University |
ClinicalTrials.gov Identifier: | NCT00679302 History of Changes |
Other Study ID Numbers: |
14415 |
First Posted: | May 16, 2008 Key Record Dates |
Results First Posted: | April 29, 2014 |
Last Update Posted: | April 29, 2014 |
Last Verified: | March 2014 |
Keywords provided by Myto Duong, St. Louis University:
skin abscess CA-MRSA |
Additional relevant MeSH terms:
Abscess Skin Diseases Communicable Diseases Infection Skin Diseases, Infectious Suppuration Inflammation Pathologic Processes Anti-Bacterial Agents Trimethoprim, Sulfamethoxazole Drug Combination Antibiotics, Antitubercular Trimethoprim Sulfamethoxazole Simethicone Aluminum hydroxide, magnesium hydroxide, drug combination |
Anti-Infective Agents Antitubercular Agents Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Antifoaming Agents Emollients Dermatologic Agents |