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

NCT07118696 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Pulmonary TB

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).

Sponsors & Collaborators

  • St George's, University of London

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Christopher Cousins, MBChB PhD · St George's, University of London

  • Sean Wasserman, MBChB PhD · St George's, University of London

  • John Eikelboom, MBBS FRCPC · Population Health Research Institute, McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2029-01-31
Completion
2030-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118696 on ClinicalTrials.gov