STREAM stage 2 clinical study enrols patients in first trial to include bedaquiline to test shortened MDR-TB treatment regimens

 

The first patients have enrolled in STREAM stage 2 clinical study at a trial site in Mongolia. The trial aims to reduce multidrug-resistant tuberculosis (MDR-TB) treatment from 24 months to 6 or 9 months, and is the first phase III trial to test the effectiveness of bedaquiline within a shortened regimen.

The current treatment standard for MDR-TB involves a complex regimen1 that not only can last up to 24 months, but also involves frequent and painful injections. This poses a significant burden both for patients and the health systems tasked with administering treatment.

This study will include bedaquiline, produced by Janssen Therapeutics, Division of Janssen Products, LP, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of two additional experimental treatment arms.

The Union, sponsors of the trial, and in collaboration with Janssen, amended the original STREAM study protocol to include an all-oral 9-month regimen and a 6-month regimen, both of which include bedaquiline. The trial’s principal investigators are from the United Kingdom’s Medical Research Council (MRC) and the collaboration is supported by the United States Agency for International Development (USAID).

STREAM is the first clinical trial of its kind in Mongolia and several other STREAM countries.

“We hope this study will mark a crucial turning point in the fight against drug-resistant TB,” said I.D. Rusen, Senior Vice President for Research and Development and Union lead for the STREAM Trial. “If successful, the results from Stage 2 will provide further evidence for adopting shorter and more simplified treatment regimens – an essential step in the worldwide effort to confront MDR-TB.”

 

1. WHO. Global Tuberculosis Report 2015. 20th Edition. Available at http://www.who.int/tb/publications/global_report/en/. Accessed March 2016.