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NCT00023335 · ClinicalTrials.gov registry record · Phase 3
TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
NCT00023335 is a Phase 3 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 1,000 participants.
The verdict
NCT00023335, a Phase 3 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
Interventions
- DRUG Isoniazid
- DRUG Rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 1995-04 |
| Est. Completion | 2001-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023335
The ClinicalTrials.gov registry entry for NCT00023335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Isoniazid is the first listed.
NCT00023335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00023335 about?
NCT00023335 is a clinical study titled "TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis". Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase...
What is the current status of trial NCT00023335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 1995-04. Estimated completion is 2001-03.
What interventions are being tested in trial NCT00023335?
The interventions under investigation include: Isoniazid (DRUG), Rifapentine (DRUG).
Who is sponsoring clinical trial NCT00023335?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
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