Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

Official Title: “Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm and 23 hr Observation Unit to Inpatient Treatment in the Management of Abscesses 5-10cm in the Pediatric Population.”

The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic versus non-antibiotic treatment after incision and drainage. We will also compare successful rates of cure and time to healing with IV antibiotics and 23-hour observation unit stay versus hospitalization with IV antibiotics for abscesses greater than 5 cm but less than 10 cm in pediatric patients.

Intervention(s) in this Clinical Trial

• Drug: oral trimethoprim/sulfamethoxazole
  • 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
• Drug: Placebo
  • Placebo caps or suspension every 12 hours for 10 days
• Other: Observational Unit Short Stay
  • Patients with abscesses greater that 5cm to 10cm randomized to Observational Short Stay unit for up to 23 hrs.
• Other: Hospitalization
  • Patients with abscesses 5-10cm may be randomized to inpatient treatment

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: TMP/SMX vs Placebo
  • subjects with abscesses less than 5cm will be randomized to either study med or placebo
• Other: Hospitalization vs. 23 HR OBS Unit
  • Patients with abscesses 5-10cm will be randomized to either inpatient stay or 23 hour short stay in the observation unit.

Primary Measures

• Proportion of patients having abscess resolution to those that do not for each of the treatment modalities employed. For the < 5 cm arm, compare the proportions of patients with successful outcomes between the placebo and TMP/SMX groups.
  • Time Frame: 3yrs
    Safety Issue?: No

Secondary Measures

• The 5 - 10 cm arm, will compare the proportions of patients with successful outcomes between the 23-hour observation and hospitalization groups.
  • Time Frame: 3yrs
    Safety Issue?: No

Inclusion Criteria:

• Fluctuant abscess on trunk, scalp, extremities and axilla.

Exclusion Criteria:

• Multiple abscesses
• Abscesses greater than 10 cm
• Abscesses located on the hands, face, and perineum
• Bite wounds
• Immunocompromised patients (including diabetes, sickle cell, chronic steroid therapy, etc.)
• Previously failed 48 hours or greater therapy on any antibiotic regimen
• Abscess less than 5 cm AND patient has (for exclusion criteria 7 - 10):
• Drug allergy to TMP/SMX
• Fever greater than or equal to 102.2 degrees F in last 24 hours
• Systemic symptoms on presentation - i.e., nausea, vomiting, diaphoresis, etc. \
• Signs/symptoms of another infection or illness - i.e., influenza, croup, etc. Abscess 5 - 10 cm AND patient has (for exclusion criterion 11): \
• Drug allergy to both Clindamycin AND Vancomycin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 90 Days

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Baylor College of Medicine Other

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691600

Study ID Number: H-18758

ClinicalTrials.gov Identifier: NCT00691600

Health Authority: United States: Institutional Review Board