NCT06081361

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

A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis
• Rifampicin-resistant Tuberculosis

Interventions

Type	Name	Description
DRUG	Bedaquiline	Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
DRUG	Delamanid	Oral, 100mg bid
DRUG	Contezolid	Oral, 800mg bid
DRUG	Levofloxacin	Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg
DRUG	Moxifloxacin	Oral, 400mg qd
DRUG	Clofazimine	Oral, 100mg qd
DRUG	Linezolid	Oral, 600mg qd
DRUG	Cycloserine	Oral, 250mg bid
DRUG	Prothionamide	Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg
DRUG	Pyrazinamide	Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg
DRUG	Para-Aminosalicylic Acid	8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg
DRUG	Ethambutol	750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg

Timeline

• Start date: 2023-12-22
• Primary completion: 2026-10-01
• Completion: 2026-12-31
• First posted: 2023-10-13
• Last updated: 2025-04-01

Locations

39 sites across 1 country: China