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

Conditions: Drug Susceptible Pulmonary Tuberculosis

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 165

Sponsor: Gates Medical Research Institute

Location: Wits RHI - Shandukani Research Johannesburg Gauteng

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.

Eligibility Criteria

Inclusion Criteria: * 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 * ≥1+ AFB smear OR positive Xpert semi-quantitative result * Molecular confirmation of M. tuberculosis * Chest X-ray consistent with TB (Investigator assessment) * Able to spontaneously produce sputum * Contraception requirements met * Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence * Males: contraception or abstinence through 90 days post-dose Exclusion Criteria: * 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 * HIV-positive AND any of the following: * Not on ART or on ART \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07517445). StuddyBuddy aggregates publicly available trial information.