Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

Abscesses Clinical Trial

Official title:

Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973765
• Other study ID #: FWH20080055H_
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2009
• Last updated: March 1, 2010
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

• Exclusion criteria include patients with diabetes, HIV, cancer or other immunocompromised patients.

• Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.

• Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.

• Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.

• Patients with fever or evidence of systemic infection

• Finally, patients with sulfa allergy will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Abscesses

Intervention

Drug:
• bactrim
bactrim DS (800/160) 2 pills PO BID x 7 days
• placebo
placebo 2 pills po BID x 7 days

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Wilford Hall Medical Center	Emergency Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failures at 7 Days	worsening abscess or new recurrence of abscess	7 days	No