Phase 3 Tuberculosis Trial, Recruiting NCT04260477 Sponsor: Institute of Tropical Medicine, Belgium Condition: Tuberculosis
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Phase 3 Tuberculosis Trial, Recruiting

NCT04260477
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been newly diagnosed with a recurring (came back) form of tuberculosis (TB) that affects the lungs, confirmed by a sputum smear test
  • People of any age, including both adults and children, may be considered
  • People who are able and willing to sign a written consent form agreeing to take part
  • For the second stage of the trial only: people who live within 5 kilometres of a health facility that has a medical doctor

Who may not be able to join:

  • People whose TB showed resistance to the antibiotic rifampicin on an initial test called Xpert MTB/RIF
  • People who have been moved to a health facility that is not supported by the Damien Foundation
  • People who were already enrolled in this trial and then developed another episode of TB (that is not resistant to rifampicin) during the study period
  • People who have significantly raised liver enzyme levels (a sign of possible liver problems) at the start of the study, or who have an active liver disease at the time of screening
  • Women who are pregnant or breastfeeding
  • People who have both TB and HIV, and whose HIV treatment requires a type of medication called a protease inhibitor

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sani Kadri, Ministry of Health, Niger

Phone: 003232470778

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Institute of Tropical Medicine, Belgium
Registry
ClinicalTrials.gov
Start date
1 March 2021
Est. completion
1 June 2025

Where this trial is recruiting

Niger

Primary endpoints

STAGE 1:number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment; STAGE 2: Describe bacterial effectiveness; STAGE 2: Describe acquired resistance

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov