Multidrug Resistant Tuberculosis Clinical Trial
Official title:
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
The purpose of this study is to assess the efficacy and safety of a molecular drug-sensitivity test-guided individualized shorter all-oral regimen composed of 4-5 anti-tuberculosis drugs recommended by WHO in RRTB patients for 9-12 months in real-world practice, in some high RR-TB burden province of China. This study hopes to form a clinical pathway of all oral short-term treatment based on the guidance of rapid molecular drug sensitivity that can be popularized in China, and update the Chinese guidelines of RR-TB treatment management.
This trial is a multi-centre prospective observational cohort study. The purpose of this study is to evaluate an individualized 9-12 month all-oral regimen in RRTB patients confirmed by phenotypic or molecular rifampicin sensitivity test. A total of 3000 participants with a shorter all-oral regimen and receiving clinical care at study sites will be estimated. Drug resistance to RIF, FQs, SLIDs, INH, Eto and PZA was evaluated before enrollment. After screening for eligibility, treatment regimen is individually designed in this trial by responsible physicians at study sites based on radiological, clinical, bacteriological as well as drug sensitivity test results. Candidate anti-TB drugs are BDQ, LZD, FQs, Cs, Cfz, Z, Dlm and INH. Follow-up visits are conducted monthly until end of treatment. After end of treatment, follow-up visits were conducted every 3 months for the first 6 months and then every 6 months until 24 months after discontinuation. The primary objective is to evaluate end of treatment outcomes. Favorable outcomes include cured and treatment completed. Unfavorable outcomes include treatment failed, lost to follow-up and died. The secondary objective is to assess the median time to sputum culture conversion, frequency of and time to relapse and frequency of recurrence-free survival. Safety evaluations performed are the routine lab tests, blood glucose, hearing, vital signs, electrocardiograph (ECG), reporting of adverse events, physical examinations and chest CT. Adverse events will be monitored and promptly managed during the whole treatment course. ;
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