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

NCT03338621 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2024-03-07

Study results available
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Summary

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)

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug-Resistant
  • Tuberculosis, MDR
  • Tuberculosis
  • Drug-Resistant Tuberculosis

Interventions

DRUG

Pretomanid

200 mg tablets

DRUG

Bedaquiline

100 mg tablets

DRUG

Moxifloxacin

400 mg tablets

DRUG

Pyrazinamide

500 mg tablets

DRUG

HRZE

isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets

DRUG

HR

isoniazid 75 mg plus rifampicin 150 mg combination tablets

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Morounfolu Olugbosi, MD MSc · Global Alliance for TB Drug Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2021-07-01
Completion
2022-06-10
FDA Drug
Yes

Countries

  • Brazil
  • Georgia
  • Malaysia
  • Philippines
  • Russia
  • South Africa
  • Tanzania
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338621 on ClinicalTrials.gov