Actively Recruiting
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
Led by Gates Medical Research Institute · Updated on 2026-04-22
165
Participants Needed
4
Research Sites
61 weeks
Total Duration
On this page
Sponsors
G
Gates Medical Research Institute
Lead Sponsor
I
IQVIA RDS Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years at consent
- Body weight 40-100 kg at screening
- Written informed consent obtained
- Newly diagnosed pulmonary tuberculosis sensitive to rifampicin and isoniazid
- At least 1 positive AFB smear or positive Xpert semi-quantitative result
- Molecular confirmation of Mycobacterium tuberculosis
- Chest X-ray consistent with tuberculosis as assessed by investigator
- Able to spontaneously produce sputum
- Contraception requirements met
- Females of childbearing potential must use 2 approved contraceptive methods or practice abstinence
- Males must use contraception or practice abstinence through 90 days post-dose
You will not qualify if you...
- Prior tuberculosis within 3 years, more than 1 prior episode, or anti-tuberculosis treatment within 60 days
- Extrapulmonary tuberculosis except non-significant pleural or lymph node disease
- Clinically significant comorbidities or substance abuse impacting safety or compliance
- Pregnant or breastfeeding
- HIV-positive with any of the following: not on ART or on ART less than 3 months, CD4 count less than 200 cells/µL, viral load greater than 200 copies/mL, or AIDS-defining illness other than pulmonary tuberculosis
- Screening laboratory abnormalities including liver function tests, hematology, hepatitis B or C, or HbA1c
- Clinically significant ECG abnormality
- Use of prohibited concomitant medications such as strong CYP3A4 modifiers or certain SSRIs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Wits RHI - Shandukani Research
Johannesburg, Gauteng, South Africa, 2001
Not Yet Recruiting
2
The Aurum Institute Clinical Research Site - Pretoria
Pretoria, Gauteng, South Africa, 87
Not Yet Recruiting
3
TASK Clinical Research Centre
Cape Town, Western Cape, South Africa, 7530
Actively Recruiting
4
Centre of Tuberculosis Research Innovation
Cape Town, Western Cape, South Africa, 7700
Not Yet Recruiting
Research Team
G
Gates MRI
CONTACT
G
Gates MRI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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