RecruitingPhase 3

Novel Triple-dose Tuberculosis Retreatment Regimen

Niger370 participantsStarted 2021-03-01

Plain-language summary

To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All newly registered patients with smear-positive recurrent pulmonary TB * Adults as well as children (no age limit) * Able and willing to provide written informed consent * Added for stage 2: lives within 5 km of a health facility with a medical doctor Exclusion Criteria: * All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing * Patients transferred to a health facility not supported by the Damien Foundation * Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period * Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening * Pregnant or breastfeeding woman * HIV co-infected patients requiring treatment with a protease inhibitor

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

STAGE 1:number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment

Timeframe: 18 months

STAGE 2: Describe bacterial effectiveness

Timeframe: 18 months

STAGE 2: Describe acquired resistance

Timeframe: 18 months

Trial details

NCT IDNCT04260477

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Natacha Herssens, MSc

003232470778 nherssens@itg.be

View on ClinicalTrials.gov More Multidrug-resistant Tuberculosis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.