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

This study has been completed.
Information provided by:
Wilford Hall Medical Center Identifier:
First received: January 26, 2009
Last updated: July 27, 2009
Last verified: June 2009
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Abscess
Intervention: Drug: Septra

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited who presented to the ER with an uncomplicated skin abscess who met inclusion criteria and did not meet exclusion criteria. Informed consent was obtained.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
No Intervention No antibiotic
Septra DS Septra DS (800/160) two pills PO BID x 7 days

Participant Flow:   Overall Study
    No Intervention     Septra DS  
STARTED     13     18  
COMPLETED     13     18  
NOT COMPLETED     0     0  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
No Intervention No antibiotic
Septra DS Septra DS (800/160) two pills PO BID x 7 days
Total Total of all reporting groups

Baseline Measures
    No Intervention     Septra DS     Total  
Number of Participants  
[units: participants]
  13     18     31  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     13     18     31  
>=65 years     0     0     0  
[units: participants]
Age 18-25     6     7     13  
Age 26-40     2     3     5  
Age 41-65     5     8     13  
[units: years]
Mean (Standard Deviation)
  33.4  (2)     34.5  (2)     34.3  (2)  
[units: participants]
Female     4     10     14  
Male     9     8     17  
Region of Enrollment  
[units: participants]
United States     13     18     31  

  Outcome Measures
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1.  Primary:   Clinical Improvement at 7 Days After Incision and Drainage   [ Time Frame: 7 days ]

2.  Secondary:   Recurrence Rates   [ Time Frame: 30 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Gillian Schmitz, MD
Organization: Wilford Hall Medical Center
phone: 919-724-9185

Responsible Party: Dr. Gillian Schmitz Identifier: NCT00829686     History of Changes
Other Study ID Numbers: FWH20080055H-Pilot
Study First Received: January 26, 2009
Results First Received: June 5, 2009
Last Updated: July 27, 2009
Health Authority: United States: Federal Government