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NOT YET RECRUITING
NCT07118696
PHASE3

Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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).