Overview
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
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 \<3 months
- CD4 \<200 cells/µL
- Viral load \>200 copies/mL
- AIDS-defining illness (other than pulmonary TB)
- Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)
- Clinically significant ECG abnormality
- Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)
