Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myto Duong, St. Louis University
ClinicalTrials.gov Identifier:
NCT00679302
First received: May 14, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.


Condition Intervention Phase
Skin Diseases, Infectious
Drug: Trimethoprim-sulfamethoxazole
Drug: Placebo group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Skin Abscess Resolution [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • New Lesion Development and Spread of Skin Abscesses [ Time Frame: 10-14 days and 3 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 161
Study Start Date: July 2006
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679302

Locations
United States, Missouri
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Investigators
Study Director: John Peter, MD St. Louis University
  More Information

Publications:
Additional 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
Study First Received: May 14, 2008
Results First Received: January 29, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
skin abscess
CA-MRSA

Additional relevant MeSH terms:
Skin Diseases
Communicable Diseases
Infection
Skin Diseases, Infectious
Anti-Bacterial Agents
Antibiotics, Antitubercular
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Sulfamethoxazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014