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

NCT ID: NCT00822692

Last Updated: 2015-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-06-30

Brief Summary

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Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

Detailed Description

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All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room 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.

Conditions

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Abscess Methicillin-Resistant Staphylococcus Aureus Infection

Keywords

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Abscess Cellulitis Antibiotics MRSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bactrim DS

Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days

Group Type ACTIVE_COMPARATOR

Trim/ Sulfa DS

Intervention Type DRUG

bactrim DS (800/160) two tablets PO BID x 7 days

matched placebo

matched placebo 2 pills orally (PO) twice a day (BID) x 7 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matched placebo 2 pills PO BID x 7 days

Interventions

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Trim/ Sulfa DS

bactrim DS (800/160) two tablets PO BID x 7 days

Intervention Type DRUG

placebo

matched placebo 2 pills PO BID x 7 days

Intervention Type DRUG

Other Intervention Names

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Bactrim

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Air Force Office of the Surgeon General

FED

Sponsor Role collaborator

Emergency Medicine Foundation

OTHER

Sponsor Role collaborator

59th Medical Wing

FED

Sponsor Role lead

Responsible Party

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Gillian Schmitz

Emergency Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gillian R Schmitz

Role: PRINCIPAL_INVESTIGATOR

59th Medical Wing

Locations

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Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20346539 (View on PubMed)

Other Identifiers

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FWH20080055H

Identifier Type: -

Identifier Source: org_study_id