MedTrace Logo

A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB

NCT02333799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-09-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture positive at month 4) in participants with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Bedaquiline

100mg tablets

DRUG

PA-824

200mg tablets

DRUG

Linezolid

Scored 600mg tablets

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

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

  • Francesca Conradie, MD · CHRU Themba Lethu Clinic - Helen Joseph Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-01-14
Completion
2020-08-03

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT02333799 on ClinicalTrials.gov