NCT02333799

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

A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Participants With Pulmonary Infection of Either XDR-TB or Treatment Intolerant / Non-responsive MDR-TB.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Up to 200 male and female participants aged 14 and over with confirmed sputum positive for M.tb. in culture pulmonary XDR-TB, or with pulmonary MDR-TB with a documented intolerability or non-response to the best treatment available for 6 months or more will be enrolled. All participants will have up to a maximum of 9 days for screening, receive 6 months of treatment, and have followup visits performed 1 and 2 months after treatment completion and every 3 months after study treatment completion for 24 months. If a participant is culture positive or revert to being culture positive between Month 4 and Month 6 visits and their clinical condition suggests they may have ongoing TB infection, they may have treatment extended to 9 months (with 24 months of Follow Up) or be withdrawn from the study. Participants who withdraw after \<14 days of IMP should attend an Early Withdrawal visit. Participants who withdraw after \>15 days of IMP should return for an Early Withdrawal visit and follow-up visits at 3, 6 and 24 months after their last dose of IMP to check for survival, SAEs and resolution of TB symptoms.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Bedaquiline	100mg tablets
DRUG	PA-824	200mg tablets
DRUG	Linezolid	Scored 600mg tablets

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-01-14
• Completion: 2020-08-03
• First posted: 2015-01-07
• Last updated: 2025-09-08
• Results posted: 2024-08-09

Locations

3 sites across 1 country: South Africa