Utility of Trimethoprim-Sulfamethoxazole Use in Skin Abscess Management

This study has been completed.
Sponsor:
Information provided by:
St. Louis University
ClinicalTrials.gov Identifier:
NCT00679302
First received: May 14, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

The purpose of this study is to determine if antibiotica 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/infection to other family members [ Time Frame: 10-14 days and 3 month ] [ Designated as safety issue: No ]

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
simethicone and bitter mixture
Other Name: Maalox
Active Comparator: antibiotic group
Trimethoprim-sulfamethoxazole suspension
Drug: Trimethoprim-sulfamethoxazole
Trimethoprim-sulfamethoxazole suspension 10-12mg/kg/day divided twice daily for 10 days
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
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, St Louis University, Cardinal Glennon Children's Medical Center
ClinicalTrials.gov Identifier: NCT00679302     History of Changes
Other Study ID Numbers: 14415
Study First Received: May 14, 2008
Last Updated: May 14, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Abscess
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Suppuration
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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 April 17, 2014