Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

August 11, 2026 updated by: Global Alliance for TB Drug Development

An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)

To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Phase 2c multi-center, open-label, partially randomized clinical trial in DS-TB and DR-TB participants.

All participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy.

Participants with Drug Sensitive TB (DS-TB):

Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either BPaMZ daily for 17 weeks (4 months), or HRZE/HR combination tablets daily for 26 weeks (6 months). participants will be stratified for co-infection with human immunodeficiency virus (HIV) and cavitation.

Participants with Drug Resistant TB (DR-TB):

Participants with DR-TB will be assigned to receive BPaMZ daily for 26 weeks (6 months).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
455

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Evandro Chagas
      • Rio de Janeiro, Brazil
        • FIOCRUZ
  • Georgia
    • K'alak'i T'bilisi
      • Tbilisi, K'alak'i T'bilisi, Georgia, 0101
        • National Center for Tuberculosis and Lung Diseases
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Perubatan Respiratori
  • Philippines
      • Manila, Philippines, 1104
        • Lung Center of Philippines
      • Manila, Philippines, 1230
        • Tropical Disease Foundation
  • Russia
      • Moscow, Russia, 107014
        • Moscow City Research and Practice Tuberculosis Treatment Centre
      • Moscow, Russia, 107564
        • Central TB Research Institute of the Federal Agency of Scientific Organizations
      • Moscow, Russia, 119991
        • Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University
      • Saint Petersburg, Russia, 191036
        • Research Institute of the Phthisiopulmonology
      • Yekaterinburg, Russia, 620039
        • Ural Research Institute of Phthisiopulmonology
  • South Africa
      • Brits, South Africa, 0250
        • Madibeng Centre for Research
      • Cape Town, South Africa, 7530
        • TASK
      • Cape Town, South Africa, 7700
        • University of Cape Town Lung Institute
      • Durban, South Africa, 4001
        • Enhancing Care Foundation
      • Durban, South Africa, 4015
        • CHRU, King Dinuzulu
      • Johannesburg, South Africa, 2092
        • CHRU, Helen Joseph Hospital
      • Klerksdorp, South Africa, 2571
        • PHRU, Tshepong Hospital
      • Port Elizabeth, South Africa, 7070
        • CHRU, Empilweni TB Hospital
      • Soshanguve, South Africa, 0152
        • Setshaba Research Centre
    • KwaZulu-Natal
      • Pietermaritzburg, KwaZulu-Natal, South Africa, 3216
        • THINK
  • Tanzania
      • Bagamoyo, Tanzania
        • Ifakara Health Institute
      • Mbeya, Tanzania
        • NIMR-Mbeya
      • Moshi, Tanzania
        • Kilimanjaro Clinical Research Institute
    • Tanzania
      • Mwanza, Tanzania, Tanzania
        • Mwanza Intervention Trials Unit
  • Uganda
      • Kampala, Uganda, 2109
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease [IUATLD]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory.
  • Participants with one of the following pulmonary TB conditions:

DS-TB treatment arm participants should be:

  • sensitive to rifampicin and isoniazid by rapid sputum based test AND
  • either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB.

DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid.

  • Of non-childbearing potential or willing to practice effective methods of birth control
  • Body weight (in light clothing and no shoes) ≥ 30 kg.
  • Completed informed consent form

Exclusion Criteria:

  • Karnofsky score <60%
  • Any risk factor for QT prolongation
  • Any planned contraindicated medicines
  • Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests).

Any of the following lab toxicities/abnormalities:

  • CD4+ count < 100 cells/µL (HIV infected participants)
  • platelets <75,000/mm³
  • creatinine >1.5 times upper limit of normal (ULN)
  • eGFR ≤ 60 mL/min
  • haemoglobin <8.0 g/dL
  • serum potassium less than the lower limit of normal for the laboratory.
  • GGT: greater than 3 x ULN
  • AST: ≥3.0 x ULN to be excluded;
  • ALT: ≥3.0 x ULN to be excluded
  • ALP: ≥3.0 x ULN to be excluded
  • Total bilirubin: >1.5 x ULN to be excluded;
  • Direct bilirubin: greater than 1x ULN to be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Drug Sensitive BPaMZ
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 9 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 17 weeks (Total treatment duration 4 months
Drug: Moxifloxacin
400 mg tablets
Other Names:
  • M
Drug: Pretomanid
200 mg tablets
Other Names:
  • PA-824
  • Pa
Drug: Bedaquiline
100 mg tablets
Other Names:
  • B
  • TMC207
Drug: Pyrazinamide
500 mg tablets
Other Names:
  • Z
Active Comparator: Drug Sensitive Standard Treatment
isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg (HRZE) combination tablets for 8 weeks AND isoniazid 75 mg + rifampicin 150 mg (HR) combination tablets for Weeks 9 to 26
Drug: HRZE
isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
Other Names:
  • isoniazid
  • rifampicin
  • ethambutol
Drug: HR
isoniazid 75 mg plus rifampicin 150 mg combination tablets
Other Names:
  • isoniazid
  • rifampicin
Experimental: Drug Resistant BPaMZ
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 18 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 26 weeks (Total treatment duration 6 months)
Drug: Moxifloxacin
400 mg tablets
Other Names:
  • M
Drug: Pretomanid
200 mg tablets
Other Names:
  • PA-824
  • Pa
Drug: Bedaquiline
100 mg tablets
Other Names:
  • B
  • TMC207
Drug: Pyrazinamide
500 mg tablets
Other Names:
  • Z

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Culture Negative Status by 8 Weeks
Time Frame: Days 0-56 (8 weeks)
Culture negative status is achieved when a participant produces at least two negative culture results at different visits (at least 7 days apart) without an intervening positive culture result for M.tb.
Days 0-56 (8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months)
Time Frame: 52 weeks after start of therapy

Unfavorable status:

  1. Participants not classified as having achieved or maintained culture negative status when last seen
  2. Participants previously classified as having culture negative status who, following the end of treatment, have two positive cultures without an intervening negative culture
  3. Participants who had a positive culture not followed by at least two negative cultures when last seen
  4. Participants dying from any cause during treatment, except from violent or accidental cause, not including suicide
  5. Participants definitely or possibly dying from TB related cause during the follow-up phase
  6. Participants requiring an extension of their treatment beyond that permitted by the protocol a restart or a change of treatment for any reason except reinfection or pregnancy
  7. Participants lost to follow up or withdrawn from the study before end of treatment
52 weeks after start of therapy
Time to Culture Negative Status
Time Frame: During treatment (17 or 26 weeks)
Culture conversion is a diagnostic criteria indicating the point at which samples taken from a patient infected with a tuberculosis can no longer produce tuberculosis cell cultures, that point is considered culture negativity
During treatment (17 or 26 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Global Alliance for TB Drug Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Morounfolu Olugbosi, MD MSc, Global Alliance for TB Drug Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SimpliciTB (B-Pa-M-Z) NC-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD from the trial will be submitted to Critical Path Institute which will make fully anonymized data available through the Tuberculosis Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. Data sets for Drug susceptibility data, Demographic data, MTB diagnostic testing results, Concomitant medications information, Adverse event information, Treatment adherence information, Co-morbidities, Treatment outcomes, HIV co-infection information, CD4 counts, TB disease symptoms from all collected IPD will be made available.

IPD Sharing Time Frame

Data is expected to become available in mid-2024.

IPD Sharing Access Criteria

Researchers must agree to the Terms and Conditions for Use of the TB-PACTS data platform and submit an online application form to request access to the data platform.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings