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Clinical Trials/CTRI/2021/03/032189
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
International Union Against Tuberculosis and Lung Disease

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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