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

May 10, 2017 updated by: Gillian Schmitz, 59th Medical Wing

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

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)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day 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 emergency room (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lackland Air Force Base, Texas, United States
        • Wilford Hall Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
No antibiotic
Active Comparator: Septra DS
Septra DS (800/160) two pills PO BID x 7 days
Drug: Septra
(800/125) PO BID X 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Improvement at 7 Days After Incision and Drainage
Time Frame: 7 days
improving wound without evidence of fever, worsening cellulitis or induration
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rates
Time Frame: 30 days
recurrence of abscess in previous or new location within 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

59th Medical Wing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20080055H-Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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