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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00973765
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 2, 2010
Last Update Posted : March 9, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Abscesses Drug: bactrim Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: bactrim DS (800/160) 2 pills po BID x 7 days
active comparator
Drug: bactrim
bactrim DS (800/160) 2 pills PO BID x 7 days
Placebo Comparator: Matched placebo 2 pills po BID x 7 days
placebo
Drug: placebo
placebo 2 pills po BID x 7 days


Outcome Measures

Primary Outcome Measures :
  1. Treatment Failures at 7 Days [ Time Frame: 7 days ]
    worsening abscess or new recurrence of abscess


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973765


Locations
United States, Texas
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Sponsors and Collaborators
Wilford Hall Medical Center
Emergency Medicine Foundation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gillian Schmitz, MD, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT00973765     History of Changes
Other Study ID Numbers: FWH20080055H_
First Posted: September 9, 2009    Key Record Dates
Results First Posted: March 2, 2010
Last Update Posted: March 9, 2010
Last Verified: September 2009

Keywords provided by Wilford Hall Medical Center:
abcess
MRSA
cellulitis
antibiotics
uncomplicated abscesses

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents