Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

NCT05766267 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 288 participants
Start Date 2023-11-21
Est. Completion 2027-12-31
Phase Phase 2

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 288 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 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05766267 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, Ouest, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05766267?

The interventions under investigation include: Moxifloxacin (DRUG), Rifabutin (DRUG), Delamanid (DRUG), Bedaquiline (DRUG), Pyrazinamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05766267?

This trial is sponsored by Centers for Disease Control and Prevention, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial