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MDR TB Trial Ends Enrollment Early After Promising Data

Médecins Sans Frontières (MSF) published a press release on World TB Day 2021 announcing their clinical trial, TB-Practecal, investigating novel treatment for MDR-TB has stopped enrolling earlier than originally planned due to promising results. The trial's independent data safety and monitoring board determined that one of the TB drug regimens being investigated is superior to the current standard of care. They have concluded that more patient data would not change these results. 

TB Practecal is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multidrug-resistant TB (MDR-TB). The trial began in 2017 and Stage 1 involved 3 experimental arms: B-Pa-Lzd-Mfx, B-Pa-Lzd-Cfz and B-Pa-Lzd and a control arm. Stage 2 enrolled into the six-month B-Pa-Lzd-Mfx investigational arm and the standard of care arm only. At the time of trial enrolment termination, a total of 552 participants have been enrolled into all four trial arms.

MSF's press release quotes Professor David Moore from London School of Hygiene and Tropical Medicine and a member of the Trial Steering Committee: "This will be the first ever multi-country, randomised, controlled clinical trial to report on the safety and efficacy of a six-month, all oral regimen for drug-resistant TB. The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long."

MSF is currently preparing a dataset to share with the World Health Organization and a full set of the results will be submitted to a peer-reviewed journal for publishing. 

 

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