Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

This study has been completed.

First Received: January 13, 2009 Last Updated: July 29, 2009 History of Changes

Sponsor:	Wilford Hall Medical Center
Collaborators:	U.S. Air Force Office of the Surgeon General Emergency Medicine Foundation
Information provided by:	Wilford Hall Medical Center
ClinicalTrials.gov Identifier:	NCT00822692

Purpose

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) septra DS two pills PO BID x 7 days or 2)placebo. Patients will then return to the ER on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.

Condition	Intervention
Abscess Methicillin-resistant Staphylococcus Aureus Infection	Drug: Septra DS Drug: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Methicillin Methicillin sodium Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:

Recurrence Rates of Abscesses [ Time Frame: 30 days after incision and drainage ] [ Designated as safety issue: No ]

Enrollment:	139
Study Start Date:	April 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bactrim DS (800/160) two tablets PO BID x 7 days: Active Comparator bactrim DS (800/160) two tablets PO BID x 7 days	Drug: Septra DS bactrim DS (800/160) two tablets PO BID x 7 days
matched placebo 2 pills PO BID x 7 days: Placebo Comparator matched placebo 2 pills PO BID x 7 days	Drug: placebo matched placebo 2 pills PO BID x 7 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All patients age 18-65 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.
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 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.
Finally, patients with sulfa allergy will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822692

Locations

United States, Texas
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236

Sponsors and Collaborators

Wilford Hall Medical Center

U.S. Air Force Office of the Surgeon General

Emergency Medicine Foundation

Investigators

Principal Investigator:

Gillian R Schmitz

Wilford Hall Medical Center

More Information

No publications provided

Responsible Party:	Wilford Hall Medical Center ( Gillian Schmitz, MD )
Study ID Numbers:	FWH20080055H
Study First Received:	January 13, 2009
Results First Received:	July 29, 2009
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00822692 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Wilford Hall Medical Center:

Abscess
Cellulitis
Antibiotics
MRSA

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Anti-Infective Agents, Urinary
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Infection
Pharmacologic Actions
Inflammation

Antimalarials
Staphylococcal Infections
Anti-Bacterial Agents
Antiparasitic Agents
Gram-Positive Bacterial Infections
Pathologic Processes
Methicillin
Therapeutic Uses
Abscess
Suppuration

ClinicalTrials.gov processed this record on February 08, 2010