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

Primary Purpose

Abscess, Methicillin-Resistant Staphylococcus Aureus Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trim/ Sulfa DS

placebo

About this trial

This is an interventional treatment trial for Abscess focused on measuring Abscess, Cellulitis, Antibiotics, MRSA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Wilford Hall Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bactrim DS

matched placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence Rates of Abscesses

Number of patient with a new abscess in same or different location as previous lesion

Secondary Outcome Measures

Full Information

NCT ID

NCT00822692

First Posted

January 13, 2009

Last Updated

December 17, 2015

Sponsor

59th Medical Wing

Collaborators

U.S. Air Force Office of the Surgeon General, Emergency Medicine Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00822692

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

59th Medical Wing

Collaborators

U.S. Air Force Office of the Surgeon General, Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abscess, Methicillin-Resistant Staphylococcus Aureus Infection

Keywords

Abscess, Cellulitis, Antibiotics, MRSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bactrim DS

Arm Type

Active Comparator

Arm Description

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

Arm Title

matched placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Trim/ Sulfa DS

Other Intervention Name(s)

Bactrim

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

matched placebo 2 pills PO BID x 7 days

Primary Outcome Measure Information:

Title

Recurrence Rates of Abscesses

Description

Number of patient with a new abscess in same or different location as previous lesion

Time Frame

30 days after incision and drainage

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gillian R Schmitz

Organizational Affiliation

59th Medical Wing

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wilford Hall Medical Center

City

Lackland AFB

State/Province

Texas

ZIP/Postal Code

78236

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

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