Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

Abscess Clinical Trial

Official title:

Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829686
• Other study ID #: FWH20080055H-Pilot
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: July 27, 2009
• Start date: June 2008
• Est. completion date: June 2008

Study information

• Verified date: June 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 (WHMC and BAMC) 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)no antibiotic or 2) bactrim DS (800/160) two tablets PO BID x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the ER on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

• patients with diabetes, HIV, cancer or other immunocompromised patients

• 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

• basic Military Trainees will also be excluded from participation

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

• patients with sulfa allergy will be excluded.

Study Design

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

Related Conditions & MeSH terms

• Abscess
• Staphylococcal Infections

Intervention

Drug:
• Septra
(800/125) PO BID X 7 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement at 7 Days After Incision and Drainage		7 days	No
Secondary	Recurrence Rates		30 days	No