This is a project to investigate a standardised treatment regimen of anti-tuberculosis drugs for patients with Multi-drug resistant Tuberculosis (MDR-TB). The questions is: can we shorten the duration of treatment and improve outcomes for patients suffering with MDR-TB?
What is this study about?
STREAM Stage 2 is assessing two new short course regimens for MDR-TB in comparison with the 9-month regimen developed in Bangladesh which is currently being evaluated in STREAM Stage 1.
In the 9-month oral regimen the new drug bedaquiline is given throughout treatment in place of the injectable kanamycin which frequently gives rise to unpleasant side-effects such as deafness. High dose moxifloxacin is replaced by levofloxacin to minimise potential cardiac side-effects such as QT prolongation.
The 6-month regimen has a shorter intensive phase, and as in the 9-month oral regimen bedaquiline is given throughout treatment and levofloxacin replaces moxifloxacin. Prothionamide and ethambutol have both been dropped.
The primary objective of the study is to assess whether either the full oral or the 6-month regimen are non-inferior to the 9-month regimen under study in Stage 1.
Who is included?
Adult patients with MDR-TB who are sensitive to fluoroquinolones, such as moxifloxacin and levofloxacin, and to kanamycin, the aminoglycoside injectable. Patients at risk of cardiac disease or those with evidence of liver disease are not eligible.
When is it taking place?
The trial started in March 2016, recruitment and follow up are expected to be completed by 2020 with results available early in 2021.
Where is it taking place?
It is expected that sites participating in Stage 1 will enrol patients to Stage 2 and there will be new sites in Africa, Asia, eastern Europe and South America.
Who is funding the study?
Stage 2 is funded by the United States Agency for International Development (USAID) and Janssen Pharmaceuticals and sponsored by The International Union Against Tuberculosis and Lung Disease.