Plain-English translation of NCT04260477 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing a new approach to treating tuberculosis that has come back or stopped responding to earlier treatment. Researchers are comparing a standard dose of four TB medications (rifampicin, isoniazid, pyrazinamide, and ethambutol) against higher doses of two of these medications—rifampicin and isoniazid—combined with the standard doses of the other two. The goal is to see if the medication with higher doses works better without creating additional drug resistance.
When tuberculosis comes back or doesn't respond well to standard treatment, it becomes much harder to cure. Doctors need better ways to treat these cases without making the bacteria even more resistant to medicines.
You likely qualify if…
You likely don't qualify if…
You will visit a trial clinic daily for direct observation of your medication (a healthcare worker watches you take your pills). You'll have at least one clinic visit each month to check how you're doing and monitor your health, including blood tests to check your liver function. After six months of treatment, you'll be checked at six months and one year later to make sure your TB hasn't come back.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
Niger
Phase
Large-scale testing
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Damien Foundation
Enrollment target
~370 participants
Started
March 2021
Primary completion
June 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Last updated on clinicaltrials.gov in April 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Natacha Herssens, MSc
Ministry of Health, Niger
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.