Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

This study has been completed.

Sponsor:

Information provided by:

Wilford Hall Medical Center

ClinicalTrials.gov Identifier:

NCT00829686

First received: January 26, 2009

Last updated: July 27, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 26, 2009
Last Updated Date	July 27, 2009
Start Date ^ICMJE	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2009)	Clinical Improvement at 7 Days After Incision and Drainage [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00829686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2009)	Recurrence Rates [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Official Title ^ICMJE	Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Brief Summary	Patients will be enrolled in a multi-center study (WHMC and BAMC) 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)no antibiotic or 2) bactrim DS (800/160) two tablets PO BID x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the ER on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Abscess
Intervention ^ICMJE	Drug: Septra (800/125) PO BID X 7 days
Study Arm (s)	No Intervention: 1 No antibiotic Active Comparator: 2 Septra DS (800/160) two pills PO BID x 7 days Intervention: Drug: Septra
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: all patients age 18-55 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 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 basic Military Trainees will also be excluded from participation 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 patients with sulfa allergy will be excluded.
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00829686
Other Study ID Numbers ^ICMJE	FWH20080055H-Pilot
Has Data Monitoring Committee	No
Responsible Party	Dr. Gillian Schmitz
Study Sponsor ^ICMJE	Wilford Hall Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Wilford Hall Medical Center
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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