Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.
None
None
Parallel
bedaquiline
DrugAdminister 400 mg orally once daily for the first two weeks, followed by 200 mg orally three times a week for the subsequent 22 weeks.
Pretomanid (Pa)
DrugAdminister 200 mg orally once daily for six months.
linezolid
DrugAdminister 600 mg orally once daily for six months.
Moxifloxacin (M)
DrugAdminister 400 mg orally once daily for six months.
Delamanid (D)
DrugAdminister 100 mg orally twice daily for six months.
Levofloxacin
DrugAdminister 800 mg orally once daily for six months.
clofazimine
DrugAdminister 100 mg orally once daily for six months.
Favorable outcomes during the treatment period
Cure: Completing 80% or more of the medication dosage as required by the protocol within 28 weeks after the start of the research treatment, with no evidence of treatment failure, and the Mycobacterium tuberculosis (MTB) cultures of the last two sputum specimens (collection interval ≥ 14 days) at the end of treatment being negative. Treatment completion: Completing more than 80% of the medication dosage as required by the protocol within 28 weeks after the start of the research treatment, with no evidence of treatment failure, but without evidence that the MTB cultures of two sputum specimens collected at an interval of at least 14 days are negative.
Favorable outcomes during the follow - up period after treatment
Cure: Negative Mycobacterium tuberculosis (MTB) sputum culture at 72 weeks after enrollment. Negative sputum culture at the last visit before loss to follow - up: If the patient is lost to follow - up before 72 weeks after enrollment and the last MTB sputum culture before loss to follow - up is negative.
Favorable outcomes with an extended follow - up period
Cure: Negative mycobacterium tuberculosis (MTB) sputum culture at 108 weeks after enrollment. Negative sputum culture at the last visit before loss to follow - up: If the patient is lost to follow - up before 108 weeks after enrollment and the last MTB sputum culture before loss to follow - up is negative.
Unfavorable outcome
Death: Occurrence of death due to any cause. Drug replacement: Permanent replacement or addition of at least one medication due to any reason, excluding adjustments based on baseline drug susceptibility. Drug discontinuation: Discontinuation of at least one medication for more than 14 consecutive days within 16 weeks after the initiation of the study treatment for any reason; after 16 weeks, if sputum conversion has occurred, drug discontinuation is not considered an adverse outcome. Treatment failure: At the end of treatment, the results of Mycobacterium tuberculosis (MTB) culture from the last two independently collected sputum specimens (with a collection interval of ≥14 days) are positive. Extended treatment: Continuation of anti - tuberculosis treatment after 28 weeks from the start of treatment. Loss to follow - up: A study participant is considered lost to follow - up if they miss two consecutive follow - up visits within 16 weeks after the initiation of the study treatment; af
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