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NCT02410772 · ClinicalTrials.gov registry record · Phase 3
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,516
- Enrollment target
NCT02410772 is a Phase 3 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 2,516 participants.
The verdict
NCT02410772, a Phase 3 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,516 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.
Interventions
- DRUG control
- DRUG rifapentine
- DRUG rifapentine and moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,516 participants |
| Start Date | 2016-01-25 |
| Est. Completion | 2021-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02410772
The ClinicalTrials.gov registry entry for NCT02410772 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,516 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 3 interventions - of which control is the first listed.
NCT02410772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02410772 about?
NCT02410772 is a clinical study titled "TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens". The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each d...
What is the current status of trial NCT02410772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,516 participants. The study started on 2016-01-25. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02410772?
The interventions under investigation include: control (DRUG), rifapentine (DRUG), rifapentine and moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT02410772?
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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