Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476210
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Brief Title:
The Safety and Efficacy of BDLBedaquiline Plus Delamanid Plus Linezolid Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis MDR-TB or Rifampicin-Resistant Tuberculosis RR-TB
Sponsor:
Beijing Chest Hospital
Organization:
Beijing Chest Hospital
Study Overview
Official Title:
The Safety and Efficacy of BDLBedaquiline Plus Delamanid Plus Linezolid Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis MDR-TB or Rifampicin-Resistant Tuberculosis RR-TB
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this investigator initiated trial IIT is to learn if a 6-9months BDL regimen bedaquiline plus delamanid plus linezolidworks to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary tuberculosis in the context of Pretomanid not available in China It will also learn about the safety of BDL regimen
The main questions it aims to answer are
1 What is the percentage of participants with favorable treatment outcome at the end of treatment
2 What are the frequency and degree of AE and SAE associated with BDL regimen
Participants will take Bedaquiline Delamanid Linezolid for 6 months option for 9 months for subjects who remain culture positive at month 4 to 6 Safety and efficacy data will be monitored and collected during treatment A 12 month follow-up will be conducted after treatment completion
The main questions it aims to answer are
1 What is the percentage of participants with favorable treatment outcome at the end of treatment
2 What are the frequency and degree of AE and SAE associated with BDL regimen
Participants will take Bedaquiline Delamanid Linezolid for 6 months option for 9 months for subjects who remain culture positive at month 4 to 6 Safety and efficacy data will be monitored and collected during treatment A 12 month follow-up will be conducted after treatment completion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None