NCT07517445SuspendedPhase 2
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 17 Apr 2026
- Primary completion date
- 14 Jun 2027
- Lead sponsor
- Gates Medical Research Institute
- Diseases
- Tuberculosis
- NCT number
- NCT07517445
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days
- Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)
Other illness
- Extrapulmonary TB (except non-significant pleural/lymph node disease)
- HIV-positive AND any of the following:
- AIDS-defining illness (other than pulmonary TB)
Lab values
- Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)
Other
- Clinically significant comorbidities or substance abuse impacting safety/compliance
- Pregnant or breastfeeding
- Not on ART or on ART <3 months
- CD4 <200 cells/µL
- Viral load >200 copies/mL
- Clinically significant ECG abnormality
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TASK Clinical Research Centre | Cape Town | South Africa | Unknown status |
| UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation) | Cape Town | South Africa | Unknown status |
| Wits RHI - Shandukani Research | Johannesburg | South Africa | Unknown status |
| The Aurum Institute Clinical Research Site - Pretoria | Pretoria | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.