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Study NCT00513799   Information provided by Washington University School of Medicine

First Received on August 8, 2007.   Last Updated on March 31, 2011   History of Changes
Results First Received: March 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Abscesses
Furunculosis
Staphylococcus Aureus Infection
Staphylococcal Skin Infections
Interventions: Drug: Mupirocin ointment
Genetic: Chlorhexidine showers
Procedure: Bleach baths (dilute)
Behavioral: Intensive education on personal hygiene

  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
No text entered.

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
Hygiene Education Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Hygiene Education + Mupirocin Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
Education + Mupirocin + Chlorhexidine Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
Education + Mupirocin + Bleach Baths Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).

Participant Flow for 2 periods

 Period 1:   One-Month Follow-Up
    Hygiene Education     Hygiene Education + Mupirocin     Education + Mupirocin + Chlorhexidine     Education + Mupirocin + Bleach Baths  
STARTED     75     75     75     75  
COMPLETED     64     62     64     54  
NOT COMPLETED     11     13     11     21  

Period 2:   Four-Month Follow-Up
    Hygiene Education     Hygiene Education + Mupirocin     Education + Mupirocin + Chlorhexidine     Education + Mupirocin + Bleach Baths  
STARTED     64     62     64     54  
COMPLETED     64     57     57     51  
NOT COMPLETED     0     5     7     3  



  Baseline Characteristics
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Reporting Groups
  Description
Hygiene Education Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Hygiene Education + Mupirocin Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
Education + Mupirocin + Chlorhexidine Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
Education + Mupirocin + Bleach Baths Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).

Baseline Measures
    Hygiene Education     Hygiene Education + Mupirocin     Education + Mupirocin + Chlorhexidine     Education + Mupirocin + Bleach Baths     Total  
Number of Participants  
[units: participants]
 		  75     75     75     75     300  
Age  
[units: years]
Mean ± Standard Deviation 		  17.37  ± 16.57     16.52  ± 16.12     18.19  ± 17.37     18.67  ± 15.29     17.61  ± 16.31  
Gender  
[units: participants]
 		         
Female     34     37     52     38     161  
Male     41     38     23     37     139  



  Outcome Measures

1.  Primary:   Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention   [ Time Frame: 1 month follow-up ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection   [ Time Frame: 1, 4 and 6 month follow-ups ]
Results not yet posted.   Anticipated Posting Date:   06/2011   Safety Issue:   No

3.  Secondary:   Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention   [ Time Frame: 4 month follow-up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Stephanie Fritz
Organization: Washington University
phone: 314-454-6050
e-mail: fritz_s@kids.wustl.edu


No publications provided by Washington University School of Medicine

Publications automatically indexed to this study:
Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80.


Responsible Party: Bernard Camins, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00513799     History of Changes
Other Study ID Numbers: 9000C4
Study First Received: August 8, 2007
Results First Received: March 2, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board





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