Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and… (NCT07517445) | Clinical Trial Compass
RecruitingPhase 2
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
South Africa165 participantsStarted 2026-04-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bactericidal Activity
Timeframe: From randomization through Day 64 (EOT)
2
Safety: SAEs
Timeframe: From randomization through Day 64 (EOT)
3
Safety: TEAEs
Timeframe: From randomization through Day 64 (EOT)
4
Safety: AESIs
Timeframe: From randomization through Day 64 (EOT)
5
Safety: TEAEs leading to treatment discontinuation
Timeframe: From randomization through Day 64 (EOT)
6
Safety: TEAEs leading to NAM dose reduction
Timeframe: From randomization through Day 64 (EOT)