NCT06476210View on ClinicalTrials.gov

The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)

PHASE4RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

BDL regimen

"Drug:bedaquiline 100mg tablets~Other Names:~Bdq TMC-207 bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week~Drug:delamanid 50mg tablets~Other Names:~Dlm OPC-67683 delamanid 100mg 2 times daily~Drug:linezolid Scored 600mg tablets~Other Names:~Lzd linezolid 600mg once daily"

Trial Locations (7)

101149

RECRUITING

Beijing Chest Hospital, Beijing

230000

NOT_YET_RECRUITING

Anhui Chest Hospital, Hefei

250000

NOT_YET_RECRUITING

Shandong Public Health Clinical Center, Jinan

410000

NOT_YET_RECRUITING

Changsha Central Hospital, Changsha

NOT_YET_RECRUITING

Hunan Chest Hospital, Changsha

430000

NOT_YET_RECRUITING

Wuhan Institute for Tuberculosis Control, Wuhan

610000

NOT_YET_RECRUITING

Public Health Clinical Meadical Center of Chengdu, Chengdu

All Listed Sponsors
collaborator

Public Health Clinical Medical Center of Chengdu

UNKNOWN

collaborator

Wuhan Institute for Tuberculosis Control

OTHER

collaborator

Changsha Central Hospital

OTHER

collaborator

Anhui Chest Hospital

OTHER

collaborator

Hunan Chest Hospital

UNKNOWN

collaborator

Shandong Public Health Clinical Center

OTHER_GOV

lead

Beijing Chest Hospital

OTHER