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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829686
First Posted: January 27, 2009
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gillian Schmitz, Wilford Hall Medical Center
Results First Submitted: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, 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
No text entered.

Reporting Groups
  Description
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.
No text entered.

Reporting Groups
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 13   18   31 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      18 100.0%      31 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[1] Age (Years)
Age 
[Units: Years]
Mean (Standard Deviation)
 33.4  (2)   34.5  (2)   34.3  (2) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age 18-25 years   6   7   13 
Age 26-40 years   2   3   5 
Age 41-65 years   5   8   13 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  30.8%      10  55.6%      14  45.2% 
Male      9  69.2%      8  44.4%      17  54.8% 
Region of Enrollment 
[Units: Participants]
     
United States   13   18   31 


  Outcome Measures
  Show All Outcome Measures

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
e-mail: gillianmd@gmail.com



Responsible Party: Gillian Schmitz, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT00829686     History of Changes
Other Study ID Numbers: FWH20080055H-Pilot
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: June 5, 2009
Results First Posted: July 28, 2009
Last Update Posted: June 9, 2017