Autopsy report · NCT07517445

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

“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.”

The sponsor’s own words in the registry.

Life of this trial

• Suspended: paused, and may or may not restart.
• 165 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Phase

Phase 2

Sponsor

Gates Medical Research Institute

Sponsor type

University, hospital or other

Conditions

Drug Susceptible Pulmonary Tuberculosis

Interventions

Bedaquiline, pretomanid, linezolid; Bedaquiline, pretomanid, linezolid; Bedaquiline, pretomanid, linezolid; Nicotinamide (NAM)

Participants

165 (planned, not actual)

Sites

4

Countries

South Africa

Trials that died the same way

• Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
  “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.” (70% match in meaning)
• A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
  “This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.” (67% match in meaning)
• BreathID Multi-center HCV Liver Breath Test Study
  “Due to FDA comments, protocol changed; new trial will be proposed shortly” (60% match in meaning)
• Pre-emptive Anakinra for Cytokine Event Reduction
  “The trial has been stopped pending FDA approval of modifications to the trial protocol.” (57% match in meaning)
• Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
  “The trial was stopped earlier than planned after an ad hoc interim analysis” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.