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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 (Responsible Party):
Gillian Schmitz, Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00822692
First received: January 13, 2009
Last updated: December 17, 2015
Last verified: December 2015
Results First Received: July 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Abscess
Methicillin-Resistant Staphylococcus Aureus Infection
Interventions: Drug: Trim/ Sulfa 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 
Overall Participants Analyzed 
[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


  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
e-mail: gillianmd@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gillian Schmitz, 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: December 17, 2015