Evaluation of the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB):Prospective Cohort Study - BEAT study

ICMR National Institute for Research inTuberculosis0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1.Men or women aged 18 years and above
•2.Multiple Drug Resistant TB documented by culture positive sputum for Mycobacterium tuberculosis with documented resistance to Rifampicin, with or without Isoniazid, AND Fluoroquinolone or a second line injectable (Pre-XDR) OR both Fluoroquinolone and a second line injectable (XDR)
•3.A minimum of two positive sputum smears for acid-fast bacilli or at least one culture positive with negative sputum smears from specimens collected no more than 6-weeks
•4.Chest X-Ray results consistent with pulmonary TB along with points 2 & 3
•5.Body weight of >=30 kg
•6.Willingness and ability to attend scheduled follow-up visits and undergo study assessments
•7.Provide written informed consent
•8.Provide consent to HIV testing (
•9.If male or female participant of childbearing potential, willingness to use effective methods of birth control

•1.Unstable disease i.e uncontrolled diabetes,cardiomyopathy,extra pulmonary TB,significant cardiac arrhythmias.
•2.Current Hepatitis B & C, HIV, alcohol, barbiturates,amphetamine,narcotic use.
•3.History of previous treatment with Bedaquiline or Delamanid.
•4.Females with positive pregnancy test at screening or planning to conceive during study or within 6 months of cessation of drugs.Males planning to conceive during study or within 6 months of cessation of drugs.
•5.Study participants with abnormal liver function test,hemogram,creatinine laboratory values.
•6. Grade II peripheral newuropathy

发起方

ICMR National Institute for Research inTuberculosis