Overview

A Phase 3 Study Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis

Status:
Completed

Trial end date:
2020-08-03

Target enrollment:

Participant gender:

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 subjects who remain culture positive at month 4) in Subjects with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).

Phase:

Phase 3

Details

Lead Sponsor:

Global Alliance for TB Drug Development

Treatments:

Bedaquiline
Diarylquinolines
Linezolid