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NCT05766267 · ClinicalTrials.gov registry record · Phase 2
Short-course Regimens for the Treatment of Pulmonary Tuberculosis
A Phase 2 study of Tuberculosis, Pulmonary and Tuberculosis Infection, sponsored by Centers for Disease Control and Prevention.
- Active
- Registry status
- Phase 2
- Development phase
- 288
- Enrollment target
- 8
- Study locations
NCT05766267 is a Phase 2 study of Tuberculosis, Pulmonary and Tuberculosis Infection that is active but no longer recruiting, run by Centers for Disease Control and Prevention. The registered enrollment target is 288 participants, above the 66-participant average among 3 other Tuberculosis, Pulmonary trials with a reported enrollment target (336% higher). The trial reports 8 study locations across 5 states.
The verdict
NCT05766267, a Phase 2 study of Tuberculosis, Pulmonary and Tuberculosis Infection, is active but no longer recruiting, sponsored by Centers for Disease Control and Prevention.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 288 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) 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. The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1) The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3) Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Rifabutin
- DRUG Delamanid
- DRUG Bedaquiline
- DRUG Pyrazinamide
Study Locations (8)
Other
- McGill University Health Centre - Montreal
- Vancouver, British Columbia Centre for Disease Control - Vancouver
- TBTC Site 30 Uganda-Case Western Reserve Research Collaboration - Kampala
Ouest
- TBTC Site 67 GHESKIO centers IMIS - Port-au-Prince
- TBTC Site 45 Les Centres Gheskio (INLR) - Port-au-Prince
Washington
- TBTC Site 26 Seattle & King County TB Control Program - Seattle
Cape Town
- TBTC Site 09 University of Cape Town Lung Institute (Pty) Ltd - Mowbray
Can Tho City
- TBTC Site 76 CAB-V. Can Tho Province, Vietnam - Thot Not District TB Unit - Can Tho
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2023-11-21 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05766267
The ClinicalTrials.gov registry entry for NCT05766267 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 66-participant average among 3 other Tuberculosis, Pulmonary trials with a reported enrollment target (336% higher). The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tuberculosis, Pulmonary appearing as the primary indexed condition, and to 5 interventions - of which Moxifloxacin is the first listed.
NCT05766267 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Other, Ouest, Washington.
Frequently Asked Questions
What is clinical trial NCT05766267 about?
NCT05766267 is a clinical study titled "Short-course Regimens for the Treatment of Pulmonary Tuberculosis". The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tu...
What is the current status of trial NCT05766267?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 288 participants. The study started on 2023-11-21. Estimated completion is 2027-12-31.
What conditions does trial NCT05766267 study?
This clinical trial studies the following conditions: Tuberculosis, Pulmonary, Tuberculosis Infection.
What interventions are being tested in trial NCT05766267?
The interventions under investigation include: Moxifloxacin (DRUG), Rifabutin (DRUG), Delamanid (DRUG), Bedaquiline (DRUG), Pyrazinamide (DRUG).
Who is sponsoring clinical trial NCT05766267?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05766267 being conducted?
This trial has 8 study locations across Washington, Ouest, Cape Town, Can Tho City. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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