CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 455 enrolled
Drug / intervention
Pretomanid +5 moredrug
Likely dose
Pretomanid 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03338621
NCT03338621Phase 3Completed
CompareCT.gov

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)

Global Alliance for TB Drug Development·interventional·Posted Nov 9, 2017·Updated Mar 7, 2024

In Brief

A Phase 3 clinical trial evaluating Pretomanid, Bedaquiline, and 4 other interventions for Tuberculosis, Pulmonary and 4 related conditions. Completed, enrolled 455 participants across 26 sites in 8 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
CountriesBrazil, Georgia, Malaysia, Philippines, Russia, South Africa, Tanzania, Uganda
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartJul 30, 2018
Primary CompletionJul 1, 2021
Study CompletionJun 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.6 years ago

Interventions

Pretomaniddrug

200 mg tablets

Bedaquilinedrug

100 mg tablets

Moxifloxacindrug

400 mg tablets

Pyrazinamidedrug

500 mg tablets

HRZEdrug

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

HRdrug

isoniazid 75 mg plus rifampicin 150 mg combination tablets