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NCT Number: NCT07517445

Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis

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.

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Key information

Conditions

Drug Susceptible Pulmonary Tuberculosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wits RHI - Shandukani Research, Johannesburg, Gauteng, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bedaquiline, pretomanid, linezolid

Drug

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

Nicotinamide (NAM)

Dietary Supplement

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

Other names: Nicotinamide also abbreviated as NAM and also known as niacinamide .

Primary outcomes

  1. Bactericidal Activity

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with sputum culture conversion SCC to negative for Mtb in MGIT liquid culture by Week 8 (Day 56, End of Treatment [EOTx]), defined as two consecutive Mtb-negative culture results, collected at least 1 day apart (i.e., not collected on the same day), occurring by Week 9 (Day 64) with no subsequent Mtb-positive cultures through Week 9 (Day 64)

  2. Safety: SAEs

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with this event

  3. Safety: TEAEs

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with this event

  4. Safety: AESIs

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with this event

  5. Safety: TEAEs leading to treatment discontinuation

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with this event

  6. Safety: TEAEs leading to NAM dose reduction

    Time frame: From randomization through Day 64 (EOT)

    Proportion of participants with this event

Secondary outcomes

  1. Bactericidal Activity

    Time frame: Randomization through Day 64 (EOT)

    Time to Sputum culture conversion to negative of Mtb in MGIT sputum culture.

  2. Bactericidal activity

    Time frame: Randomization through Day 56 (EOTx)

    Proportion of participants with Mtb-negative MGIT sputum culture(s) at Week 4 (Day 29) and Week 8 (Day 56, EOTx), where confirmation of negative sputum culture at subsequent study timepoint is not required.

  3. Evaluate the PK of NAM when administered with BPaL in Group 1 and 2

    Time frame: Day 1 and Day 14

    Concentrations of NAM and its primary metabolite by measuring specific PK parameters at Day 1 and Day 14 (see protocol).

Study contacts

Contact information is provided by the study sponsor or research team.

Gates MRI

CONTACT

[email protected]

+857-702-2108

Gates MRI

CONTACT

[email protected]

+1-866-789-5757

Sponsors and collaborators

Lead sponsor

Gates Medical Research Institute

Other

Collaborators

  • IQVIA RDS Inc.

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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