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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGates Medical Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-65 years at consent

Body weight 40-100 kg at screening

Written informed consent obtained

Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive

Disqualifiers

Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days

Extrapulmonary TB (except non-significant pleural/lymph node disease)

Clinically significant comorbidities or substance abuse impacting safety/compliance

Pregnant or breastfeeding

Trial design

Treatments tested in this trial

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

Treatment groups

165 Participants
are divided into 3 treatment groups

Sponsors and collaborators