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

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ClinicalTrials.gov Identifier: NCT00869518
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 26, 2009
Results First Posted : April 21, 2014
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Staphylococcus Aureus
HIV Infections
Interventions Drug: rifabutin plus trimethoprim sulfamethoxazole
Drug: placebo plus trimethoprim-sulfamethoxazole
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 6 6
Completed 5 5
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Rifabutin Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
42.3
(25 to 49)
43.5
(25 to 63)
42.9
(25 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
2
  33.3%
3
  25.0%
Male
5
  83.3%
4
  66.7%
9
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Eradication of S. Aureus Colonization
Hide Description Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Time Frame 30 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Eradication of S. Aureus Colonization
Hide Description Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Time Frame 7 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
3 1
3.Secondary Outcome
Title Eradication of S. Aureus Colonization
Hide Description Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Time Frame 60 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Recurrent Skin and Skin Structure Infections (SSTI)
Hide Description recurrent SSTI was by self-report and exam, followed until positive colonization
Time Frame up to 30 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
participants were followed until colonization; therefore, no participants were followed past 30 days
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame 30 days after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rifabutin Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Rifabutin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rifabutin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rifabutin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/6 (16.67%)    
Immune system disorders     
Hypersensitivity reaction   0/6 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian S. Schwartz, MD
Organization: University of California, San Francisco
Phone: 415-476-5767
EMail: brian.schwartz@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00869518     History of Changes
Other Study ID Numbers: 08033578
First Submitted: March 24, 2009
First Posted: March 26, 2009
Results First Submitted: March 13, 2014
Results First Posted: April 21, 2014
Last Update Posted: May 14, 2014