Recruiting NCT07517445
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bedaquiline, pretomanid, linezolid, Bedaquiline, pretomanid, linezolid, Bedaquiline, pretomanid, linezolid, Nicotinamide (NAM).
- Who it may be relevant to
- Registry conditions: Drug Susceptible Pulmonary Tuberculosis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug Bedaquiline, pretomanid, linezolid
Group 1 (Approximately 55 participants), Combination of NAM 1500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days - Drug Bedaquiline, pretomanid, linezolid
Group 2 (Approximately 55 participants): Combination of NAM 2500 mg BID with bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days - Drug Bedaquiline, pretomanid, linezolid
Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days - Dietary supplement Nicotinamide (NAM)
Group 1 (Approximately 55 participants), Combination of NAM 2500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days
Primary outcome measures
- Bactericidal Activity [Time frame: From randomization through Day 64 (EOT)]
- Safety: SAEs [Time frame: From randomization through Day 64 (EOT)]
- Safety: TEAEs [Time frame: From randomization through Day 64 (EOT)]
- Safety: AESIs [Time frame: From randomization through Day 64 (EOT)]
- Safety: TEAEs leading to treatment discontinuation [Time frame: From randomization through Day 64 (EOT)]
- Safety: TEAEs leading to NAM dose reduction [Time frame: From randomization through Day 64 (EOT)]
Secondary outcome measures (3)
- Bactericidal Activity [Time frame: Randomization through Day 64 (EOT)]
- Bactericidal activity [Time frame: Randomization through Day 56 (EOTx)]
- Evaluate the PK of NAM when administered with BPaL in Group 1 and 2 [Time frame: Day 1 and Day 14]
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Africa · 4 centers
- Wits RHI - Shandukani Research — Johannesburg
- The Aurum Institute Clinical Research Site - Pretoria — Pretoria
- TASK Clinical Research Centre — Cape Town
- UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation) — Cape Town
Identifiers
NCT: NCT07517445 · Gates MRI TBD15-201