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

This study has been completed.
Sponsor:
Collaborators:
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00822692
First received: January 13, 2009
Last updated: July 29, 2009
Last verified: July 2009
Results First Received: July 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Abscess
Methicillin-resistant Staphylococcus Aureus Infection
Interventions: Drug: Septra DS
Drug: placebo

  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 enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were assigned by block randomization and data was analyzed with intention to treat analysis.

Reporting Groups
  Description
Bactrim DS (800/160) Two Tablets PO BID x 7 Days Active Intervention Arm
Matched Placebo 2 Pills PO BID x 7 Days Placebo arm

Participant Flow:   Overall Study
    Bactrim DS (800/160) Two Tablets PO BID x 7 Days     Matched Placebo 2 Pills PO BID x 7 Days  
STARTED     63 [1]   76 [1]
COMPLETED     46 [2]   51 [3]
NOT COMPLETED     17     25  
Lost to Follow-up                 17                 25  
[1] July 1, 2008
[2] June 1, 2009
[3] June 1 , 2009



  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.
No text entered.

Reporting Groups
  Description
Bactrim DS (800/160) Two Tablets PO BID x 7 Days Active Intervention Arm
Matched Placebo 2 Pills PO BID x 7 Days Placebo arm
Total Total of all reporting groups

Baseline Measures
    Bactrim DS (800/160) Two Tablets PO BID x 7 Days     Matched Placebo 2 Pills PO BID x 7 Days     Total  
Number of Participants  
[units: participants]
  63     76     139  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     63     76     139  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  31.6  ± 13     30.6  ± 13     31.06  ± 13  
Gender  
[units: participants]
     
Female     18     35     53  
Male     45     41     86  
Region of Enrollment  
[units: participants]
     
United States     63     76     139  



  Outcome Measures

1.  Primary:   Recurrence Rates of Abscesses   [ Time Frame: 30 days after incision and drainage ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Gillian Schmitz, MD
Organization: Wilford Hall Medical Center
phone: 919-724-9185
e-mail: gillianmd@gmail.com


No publications provided by Wilford Hall Medical Center

Publications automatically indexed to this study:

Responsible Party: Gillian Schmitz, MD, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT00822692     History of Changes
Other Study ID Numbers: FWH20080055H
Study First Received: January 13, 2009
Results First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: United States: Federal Government