RecruitingPhase 2NCT07525427

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis

A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis

Sponsor

Gates Medical Research Institute

Enrollment

150 participants

Start Date

Apr 14, 2026

Study Type

INTERVENTIONAL

Conditions

Drug Susceptible Pulmonary Tuberculosis

Summary

The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bedaquiline, pretomanid and TBD09, a drug called Bedaquiline, pretomanid and TBD09, and others for people with drug susceptible pulmonary tuberculosis. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBedaquiline, pretomanid and TBD09

Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days

DRUGBedaquiline, pretomanid and TBD09

Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUGBedaquiline, pretomanid and TBD09

Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUGBedaquiline, pretomanid and TBD09

Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUGBedaquiline, pretomanid and linezolid

Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

Locations(13)

Enhancing Care Foundation at Wentworth Hospital

Durban, Bluff, South Africa

TASK Applied Science - Eden

George, Central, South Africa

Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital

Johannesburg, Gauteng, South Africa

The Aurum Institute Tembisa

Tembisa, Gauteng, South Africa

CHRU @ Isango Lethemba

Bethelsdorp, Gqeberha, South Africa

Madibeng Centre for Research

Brits, North West, South Africa

Setshaba Research Center

Pretoria, Soshangue, South Africa

ONE MRI