CTRI/2021/03/032189
Not yet recruiting
Phase 3
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: J988- Other specified respiratory disorders
- Sponsor
- International Union Against Tuberculosis and Lung Disease
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •. 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.
Exclusion Criteria
- •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/µL;
- •6\. Currently having an uncontrolled cardiac arrhythmia that requires medication
- •7\. Have any of the following QTcF interval characteristics
Outcomes
Primary Outcomes
Not specified
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