Status:
UNKNOWN
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 includin...
Eligibility Criteria
Inclusion
- Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening
- Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation
- Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB)
- Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase
- Is willing to undergo human immunodeficiency virus (HIV) testing
Exclusion
- Has received prior treatment with bedaquiline
- Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks
- Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert
- Has a known allergy or intolerance to bedaquiline or other drugs in the regimen
- Is infected with a strain of nontuberculous mycobacteria
- Is HIV-positive
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 8 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05306223
Start Date
May 10 2022
End Date
August 8 2025
Last Update
January 18 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Chest Hospital
Beijing, China, 101149
2
The Eighth Medical Center of PLA General Hospital
Beijing, China
3
Changsha Central Hospital
Changsha, China
4
Public health clinical medical center of Chengdu
Chengdu, China