Clinical trial NCT05306223: A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tuberculosis, Multidrug-Resistant
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.


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

Primary outcomes:
measure: Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment
timeFrame: At the end of treatment (Week 40)
Secondary outcomes:
measure: Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment
timeFrame: At 48 weeks post the end of treatment (Week 88)
measure: Percentage of Participants Achieving Treatment Success at the end of Treatment
timeFrame: At the end of treatment (Week 40)
measure: Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment
timeFrame: At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88)
measure: Percentage of Participants Experiencing All-cause Mortality
timeFrame: Up to Week 88
measure: Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up
timeFrame: During study treatment and follow-up (From Week 1 up to Week 88)
measure: Percentage of Participants Experiencing TEAEs
timeFrame: From Week 1 up to Week 88
measure: Percentage of Participants with TB Relapses and Re-infections During the Treatment-free Follow-up Phase
timeFrame: During the treatment-free follow-up phase (Up to 48 weeks)
measure: Percentage of Participants Whose Isolates Develop Resistance to Bedaquiline and Other Drugs Used in the Regimen
timeFrame: Up to Week 88
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital
city: Beijing
country: China
facility: The Eighth Medical Center of PLA General Hospital
city: Changsha
country: China
facility: Changsha Central Hospital
city: Chengdu
country: China
facility: Public health clinical medical center of Chengdu
city: Chongqing
country: China
facility: Chongqing Public Health Medical Center
city: Fuzhou
country: China
facility: The Pulmonary Hospital of Fuzhou in Fujian Province（The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province）
city: Guiyang
country: China
facility: Guiyang Public Health Clinical Center
city: Hefei
country: China
facility: Anhui Chest Hospital
city: Heilongjiang
country: China
facility: Infectious Disease Hospital of Heilongjiang Province
city: Jiamusi
country: China
facility: Jiamusi Tumor Hospital
city: Jiangxi
country: China
facility: Jiangxi Chest Hospital
city: Shandong
country: China
facility: Shandong public health clinical center
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: Shenyang Chest Hospital
city: Wuhan
country: China
facility: Wuhan Pulmonary Hospital
city: Xi'an
country: China
facility: Xi'an Chest Hospital
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
Study officials:
affiliation: Beijing Chest Hospital
name: Mengqiu Gao
role: PRINCIPAL_INVESTIGATOR
References: