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NCT00023452 · ClinicalTrials.gov registry record · Phase 3
Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,053
- Enrollment target
NCT00023452: Completed Phase 3 study, sponsored by Centers for Disease Control and Prevention.
NCT00023452 is a Phase 3 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 8,053 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (944% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00023452, a Phase 3 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,053 participants
- Enrollment target
Study Summary
Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).
Primary Outcome
Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis \[MTB\]) and those \<18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease \[cough, fever, night sweats, weight loss, or hemoptysis\] based on history or physical exam plus radiograph, computed tomography \[CT\] scan, other diagnostic tests PLUS response to antituberculosis therapy
Interventions
- DRUG RPT + INH once weekly for 3 months given by DOT
- DRUG Isoniazid (INH) daily for 9 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,053 participants |
| Start Date | 2001-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT00023452 record still lists
NCT00023452 is an interventional study that assigns participants to a tested intervention. Its 8,053 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (944% higher).
The record links to 0 conditions, and to 2 interventions - of which RPT + INH once weekly for 3 months given by DOT is the first listed.
NCT00023452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00023452 about?
NCT00023452 is a clinical study titled "Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection". Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-...
What is the current status of trial NCT00023452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,053 participants. The study started on 2001-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00023452?
The interventions under investigation include: RPT + INH once weekly for 3 months given by DOT (DRUG), Isoniazid (INH) daily for 9 months (DRUG).
Who is sponsoring clinical trial NCT00023452?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00023452's enrollment target sits among peer trials
8,053 32nd of 2000 higher than 1,969 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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