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

NCT07517445 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Drug Susceptible Pulmonary Tuberculosis

Interventions

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

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

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • Gates Medical Research Institute

    lead OTHER

Principal Investigators

  • Gates MRI · Gates Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2027-06-14
Completion
2027-06-14

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07517445 on ClinicalTrials.gov