Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
Recruiting
Phase 2
Interventional Study
Drug Susceptible Pulmonary Tuberculosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 165 (estimated)
- Sponsor
- Gates Medical Research Institute · Other
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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.
Trial Locations
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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
*…
Contacts