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

This study has been completed.
Sponsor:
Collaborator:
Emergency Medicine Foundation
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00973765
First received: September 8, 2009
Last updated: March 1, 2010
Last verified: September 2009
  Purpose

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 Intervention Phase
Abscesses
Drug: bactrim
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Treatment Failures at 7 Days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    worsening abscess or new recurrence of abscess


Enrollment: 212
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Wilford Hall Medical Center

Additional 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_
Study First Received: September 8, 2009
Results First Received: January 19, 2010
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

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 Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 20, 2014