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Clinical trialNCT05766267Active, not recruitingPhase 2/PHASE3Interventional

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

SponsorCenters for Disease Control and PreventionEnrollment288Tuberculosis InfectionTuberculosis, Pulmonary
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Mcgill University Health Centre

    Montreal, Canada

  • Vancouver, British Columbia Centre for Disease Control

    Vancouver, Canada

Haiti
  • Tbtc Site 45 Les Centres Gheskio (inlr)

    Port-au-Prince, Ouest, Haiti

  • Tbtc Site 67 Gheskio Centers Imis

    Port-au-Prince, Ouest, Haiti

South Africa
  • Tbtc Site 09 University of Cape Town Lung Institute (pty) Ltd

    Mowbray, Cape Town, South Africa

Uganda
  • Tbtc Site 30 Uganda-Case Western Reserve Research Collaboration

    Kampala, Uganda

United States
  • Tbtc Site 26 Seattle & King County Tb Control Program

    Seattle, Washington, United States

Vietnam
  • Tbtc Site 76 Cab-V. Can Tho Province, Vietnam - Thot Not District Tb Unit

    Can Tho, Can Tho City, Vietnam

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
21 Nov 2023
Primary completion
31 Dec 2026
Completion
31 Dec 2027
Last update posted
19 Sept 2025
Registered enrollment
288
Registry id
NCT05766267

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.