A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
Launched by BEIJING CHEST HOSPITAL · Mar 23, 2022
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for patients with multidrug-resistant tuberculosis (MDR-TB) in China. The researchers want to see how effective and safe a short course of medication that includes bedaquiline is, compared to another short course that does not include this drug. Multidrug-resistant tuberculosis is a serious condition where the bacteria causing TB do not respond to standard treatments, making it harder to cure.
To participate in the trial, patients should be between 18 and 75 years old and have a confirmed MDR-TB diagnosis with specific resistance to certain drugs. They must also agree to use effective birth control during the treatment phase and be willing to undergo HIV testing. Participants will receive treatment for about 40 weeks and will be closely monitored throughout the study. This trial is important because it could lead to better treatment options for those struggling with this challenging form of tuberculosis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Beijing Chest Hospital
Beijing Chest Hospital, a leading institution in respiratory medicine, is dedicated to advancing healthcare through innovative research and clinical trials. With a focus on improving diagnosis, treatment, and prevention of respiratory diseases, the hospital collaborates with experts in various fields to conduct rigorous clinical studies. Its state-of-the-art facilities and commitment to patient-centered care position it at the forefront of medical research, contributing significantly to the global understanding of pulmonary health and enhancing therapeutic options for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Beijing, , China
Shanghai, Shanghai, China
Changsha, , China
Xinxiang, , China
Hefei, , China
Shenyang, , China
Xi'an, , China
Guiyang, , China
Jiamusi, , China
Beijing, , China
Chengdu, , China
Chongqing, , China
Fuzhou, , China
Heilongjiang, , China
Jiangxi, , China
Shandong, , China
Wuhan, , China
Patients applied
Trial Officials
Mengqiu Gao
Principal Investigator
Beijing Chest Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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