Clinical Trial

Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis

Suspended Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
A temporary precautionary pause in enrolment into all arms of the trial was implemented on 21 July 2026, due to emerging hepatic safety signal. A protocol amendment is currently underway.
Summary
The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.
Protocol Amendment History 3 changes
critical Recruitment suspended 2026-08-11
critical Recruitment suspended: A temporary precautionary pause in enrolment into all arms of the trial was implemented on 21 July 2026, due to em... 2026-08-11
critical Recruitment opened 2026-04-23
Trial Details
NCT Number NCT07517445
Lead Sponsor Gates Medical Research Institute
Collaborators: IQVIA RDS Inc.
Conditions Drug Susceptible Pulmonary Tuberculosis
Enrollment 165 participants
Start Date 2026-04-17
Primary Completion 2027-06-14 (estimated)
Study Completion 2027-06-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-10