RIFAstrat is a Phase 3, double-blind, placebo-controlled, non-inferiority trial to compare the 6-month standard treatment for DS-TB with a 4-month optimised- rifampicin based regimen provided to individuals with limited disease severity.
Aged 12 years and over
Clinical and/or radiological evidence of pulmonary TB
At least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF or Ultra within 30 days of screening confirming rifampicin-sensitive TB
Have limited TB disease defined as having a cycle threshold on sputum Xpert MTB/RIF or Ultra corresponding to 'medium' or below for bacterial burden at screening (where results from more than one test are available at screening, eligibility will be determined by the highest grade)
Received more than 7 days treatment for index TB episode
Previous treatment for active TB disease in past 12 months
M. tuberculosis with known resistance to rifampicin or isoniazid
Weight < 30 kg at screening
Hamilton Health Sciences Corporation
Lead sponsor
St George's, University of London
Collaborator
McMaster University
Collaborator