NCT05306223

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

Type	Name	Description
DRUG	Bedaquiline	Bedaquiline uncoated tablets will be administered orally.
DRUG	Levofloxacin	Levofloxacin filmcoated will be administered orally
DRUG	Linezolid	Linezolid tablets will be administered orally
DRUG	Cycloserine	Cycloserine capsules will be administered orally.
DRUG	Clofazimine	Clofazimine capsules will be administered orally.
DRUG	Pyrazinamide	Pyrazinamide tablets will be administered orally.
DRUG	Protionamide	Protionamide enteric-coated tablets will be administered orally.

Timeline

• Start date: 2022-05-10
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2022-04-01
• Last updated: 2023-01-18

Locations

17 sites across 1 country: China