Evaluate the effectiveness, safety and tolerability of various doses of Linezolid in combination with Bedaquiline and Pretomanid in Adults with Pre-Extensively Drug-Resistant (Pre-XDR), Or Treatment Intolerant/Non-responsive Multidrug-Resistant (MDRTI/NR) Pulmonary Tuberculosis in India - Modified BPaL regimen

International Union Against Tuberculosis and Lung Disease0 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

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•. Adults aged between 18 years â?? 65 years
•2. Pulmonary XDR-TB, MDRFQ, or SLI patients [with documented evidence of resistance to rifampicin with or without isoniazid resistance AND additional resistance to fluoroquinolones or SLIs by conventional DST (culture-based1) or rapid DST (Xpert MTB/RIF or LPA) from a certified laboratory] OR MDR-TBTI/NR patients [with documented intolerance or non-response to MDR TB treatment regimen for 6-months or more when the participant was adherent to the treatment regimen]
•3. Bodyweight of >=30 kg (in light clothing and no shoes)
•4. Provide written, informed consent before all study-related procedures
•5. Provide consent to HIV testing2 (if an HIV test was performed within 1 month before the study start, it should not be repeated as long as documentation can be provided [ELISA and/or Western Blot]).
•6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) < 2.5 x ULN; Total bilirubin lesser than ULN when accompanied by an increase in other liver function tests.
•7. QTcF less than or equal to 450 at baseline
•8. Female patients should not be pregnant or should be using a birth control method. They should be willing to continue practicing birth control methods (barrier or non-barrier contraceptive methods including oral contraceptives) throughout the treatment period, or history of post-menopausal for the past 12 months.

•Non-DST based criteria
•1. Intolerance or risk of toxicity from medicine in the treatment regimens (e.g. drug-drug interactions)
•2. Patient who has received more than 2 weeks of Bedaquiline or Linezolid before the first dose of BPaL regimen
•3. Pregnancy or Lactating women
•4. All forms of Extrapulmonary TB (Lymph node TB associated with Pulmonary DR-TB and pleural effusion associated with pulmonary TB can be considered for inclusion )
•. HIV infected patient having a CD4+ cell count of <= 50 cells/ÂµL;
•6. Currently having an uncontrolled cardiac arrhythmia that requires medication
•7. Have any of the following QTcF interval characteristics

发起方

International Union Against Tuberculosis and Lung Disease