drugset / Trial / NCT07209761

A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis

NCT07209761

RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.

Timeline

Start
2025-10-16
Primary completion
2027-05-28
Completion
2028-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Bedaquiline Small molecule 100 mg
Subject Bedaquiline Small molecule 200 mg
Subject Linezolid Other / unclassified 600 mg
Subject Moxifloxacin Small molecule 400 mg
Subject Pretomanid Small molecule 200 mg
Subject Quabodepistat Small molecule 30 mg