Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00869518
First received: March 24, 2009
Last updated: April 23, 2014
Last verified: April 2014
Results First Received: March 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Staphylococcus Aureus
HIV Infections
Interventions: Drug: rifabutin plus trimethoprim sulfamethoxazole
Drug: placebo plus trimethoprim-sulfamethoxazole

  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
Rifabutin

Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole

rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Placebo

Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole

placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days


Participant Flow:   Overall Study
    Rifabutin     Placebo  
STARTED     6     6  
COMPLETED     5     5  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  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
Rifabutin

Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole

rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Placebo

Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole

placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Total Total of all reporting groups

Baseline Measures
    Rifabutin     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
Mean ( Full Range )
  42.3  
  ( 25 to 49 )  
  43.5  
  ( 25 to 63 )  
  42.9  
  ( 25 to 63 )  
Gender  
[units: participants]
     
Female     1     2     3  
Male     5     4     9  
Region of Enrollment  
[units: participants]
     
United States     6     6     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Eradication of S. Aureus Colonization   [ Time Frame: 30 days following completion of treatment ]

2.  Secondary:   Eradication of S. Aureus Colonization   [ Time Frame: 7 days following completion of treatment ]

3.  Secondary:   Eradication of S. Aureus Colonization   [ Time Frame: 60 days following completion of treatment ]

4.  Secondary:   Recurrent Skin and Skin Structure Infections (SSTI)   [ Time Frame: up to 30 days following completion of treatment ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brian S. Schwartz, MD
Organization: University of California, San Francisco
phone: 415-476-5767
e-mail: brian.schwartz@ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00869518     History of Changes
Other Study ID Numbers: 08033578
Study First Received: March 24, 2009
Results First Received: March 13, 2014
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board