Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease
Sponsor: Hamilton Health Sciences Corporation
Summary
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.
Official title: Shortening TB Treatment With Optimised Rifampicin-Based Therapy and Disease Stratification: A Pragmatic Phase 3 Double-Blind Placebo-Controlled Randomised Trial (RIFAstrat)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-02-01
Completion Date
2030-01-31
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Extra 600mg of Rifampicin
Intervention group participants will receive standard treatment (RHZE), plus an optimised regimen consisting of RIfampicin at 20 mg/kg (additional 600mg rifampicin in each weight band) during a shortened treatment period of 16 weeks.
Placebo
The standard treatment regimen for DS-TB (rifampicin at 10 mg/kg and isoniazid for 6 months, plus pyrazinamide and ethambutol for the first 2 months; 2RHZE/4RH), with additional placebo for the first 4 months (16 weeks).