Pragmatic Clinical Trial for a more Effective Concise and Less toxic MDR-TB treatment regimen(s) (TB-PRACTECAL)

Author: Dr Ronelle Moodliar

THINK has proudly participated in the MSF sponsored TB-PRACTECAL clinical research trial since 2017, a phase II/III clinical trial sponsored by Médecins Sans Frontières/Doctors Without Borders (MSF), that tested a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM), amongst 2 others, against the locally accepted standard of care. At the time of the interim analysis 242 patients had been enrolled in seven trial sites across Belarus, South Africa and Uzbekistan. In March 2021, TB-PRACTECAL was terminated earlier than expected for efficacy, at which point, 552/640 patients were enrolled.

MSF submitted a dataset of the interim results to the World Health Organization (WHO) in August 2021, and following review, the WHO submitted a rapid communication for key changes to the treatment of DR-TB in May 2022. The new recommendations were highly influenced by the TB-PRACTECAL trial results.

Trial results show that treatment with BPaLM was more effective and had a better safety profile than the standard of care. The new regimen will potentially save many more lives and contribute significantly towards a better quality of life for DR-TB patients whilst taking treatment. Full results of the trial were submitted to a peer-reviewed journal in January 2022 and has been queued for publication.

This news is a resounding success for the THINK Hillcrest and Doris Goodwin clinical trial teams that have contributed towards 163 out of the 552 (30%) participants enrolled into the study that effectively informed new WHO guidelines for DR-TB. We are so proud of this achievement!

See full WHO announcement here:

https://www.who.int/news/item/02-05-2022-who-issues-rapid-communication-on-updated-guidance-for-the-treatment-of-drug-resistant-tuberculosis

The THINK Doris Goodwin clinical trial team (top) and the Hillcrest clinical trial team have contributed towards the new WHO guidelines for DR-TB.

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