drugset
drugset / Trial / NCT06081361

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

NCT06081361 ↗

Phase 3 Active not recruiting 186 enrolled Beijing Chest Hospital National Medical Center for Infectious Diseases · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: * Is the efficacy of short regimen non-inferior to standard regimen? * Is the short regimen safe enough to replace the standard regimen? Participants will: * Be given with either short or standard regimen for RR-TB treatment * Be asked to complete the scheduled visit as planned.

Timeline

Start
2023-12-22
Primary completion
2026-10-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Contezolid Small molecule 800 mg Oral
Comparator Cycloserine Small molecule 250 mg Oral
Subject Delamanid Small molecule 100 mg Oral
Comparator Ethambutol Small molecule 750 mg —
Comparator Ethambutol Small molecule 1000 mg —
Comparator Linezolid Other / unclassified 600 mg Oral
Comparator Protionamide Small molecule 600 mg Oral
Comparator Protionamide Small molecule 800 mg Oral
Comparator Pyrazinamide Small molecule 1500 mg Oral
Comparator Pyrazinamide Small molecule 1750 mg Oral
Comparator para-aminosalicylic acid Unknown 8000 mg —
Comparator para-aminosalicylic acid Unknown 10000 mg —
Background Bedaquiline Small molecule 200 mg Oral
Background Clofazimine Small molecule 100 mg Oral
Background Levofloxacin Small molecule 400 mg Oral
Background Levofloxacin Small molecule 600 mg Oral
Background Levofloxacin Small molecule 750 mg Oral
Background Moxifloxacin Small molecule 400 mg Oral

Indications

pulmonary tuberculosis rifampicin-resistant tuberculosis