Trial Outcomes & Findings for Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults (NCT NCT00869518)
NCT ID: NCT00869518
Last Updated: 2014-05-14
Results Overview
Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
30 days following completion of treatment
Results posted on
2014-05-14
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults
Baseline characteristics by cohort
| Measure |
Rifabutin
n=6 Participants
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
n=6 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
n=5 Participants
|
43.5 years
n=7 Participants
|
42.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days following completion of treatmentEradication was measured by performing cultures for S aureus at the nose, throat, and groin
Outcome measures
| Measure |
Rifabutin
n=5 Participants
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
n=5 Participants
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
|
|---|---|---|
|
Eradication of S. Aureus Colonization
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 days following completion of treatmentEradication was measured by performing cultures for S aureus at the nose, throat, and groin
Outcome measures
| Measure |
Rifabutin
n=6 Participants
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
n=5 Participants
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
|
|---|---|---|
|
Eradication of S. Aureus Colonization
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 60 days following completion of treatmentPopulation: Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.
Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 days following completion of treatmentPopulation: participants were followed until colonization; therefore, no participants were followed past 30 days
recurrent SSTI was by self-report and exam, followed until positive colonization
Outcome measures
| Measure |
Rifabutin
n=6 Participants
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
n=6 Participants
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
|
|---|---|---|
|
Recurrent Skin and Skin Structure Infections (SSTI)
|
0 participants
|
0 participants
|
Adverse Events
Rifabutin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rifabutin
n=6 participants at risk
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
n=6 participants at risk
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
|
|---|---|---|
|
Immune system disorders
Hypersensitivity reaction
|
0.00%
0/6 • 30 days after treatment
|
16.7%
1/6 • Number of events 1 • 30 days after treatment
|
Additional Information
Brian S. Schwartz, MD
University of California, San Francisco
Phone: 415-476-5767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place