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

Primary Purpose

Abscesses

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bactrim
placebo
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscesses focused on measuring abcess, MRSA, cellulitis, antibiotics, uncomplicated abscesses

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wilford Hall Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bactrim DS (800/160) 2 pills po BID x 7 days

Matched placebo 2 pills po BID x 7 days

Arm Description

active comparator

placebo

Outcomes

Primary Outcome Measures

Treatment Failures at 7 Days
worsening abscess or new recurrence of abscess

Secondary Outcome Measures

Full Information

First Posted
September 8, 2009
Last Updated
March 1, 2010
Sponsor
59th Medical Wing
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00973765
Brief Title
Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
59th Medical Wing
Collaborators
Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscesses
Keywords
abcess, MRSA, cellulitis, antibiotics, uncomplicated abscesses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bactrim DS (800/160) 2 pills po BID x 7 days
Arm Type
Active Comparator
Arm Description
active comparator
Arm Title
Matched placebo 2 pills po BID x 7 days
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
bactrim
Intervention Description
bactrim DS (800/160) 2 pills PO BID x 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 2 pills po BID x 7 days
Primary Outcome Measure Information:
Title
Treatment Failures at 7 Days
Description
worsening abscess or new recurrence of abscess
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20346539
Citation
Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. Erratum In: Ann Emerg Med. 2010 Nov;56(5):588.
Results Reference
derived

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

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