NCT04260477RecruitingPhase 3
Novel Triple-dose Tuberculosis Retreatment Regimen
Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger
Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 3 Feb 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Diseases
- Tuberculosis
- NCT number
- NCT04260477
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 370
- From 1 Mar 2021 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period
- HIV co-infected patients requiring treatment with a protease inhibitor
Other illness
- Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening
Other
- 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
- Pregnant or breastfeeding woman
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Damien Foundation Coordinator of this site? Confirm its status | Niamey | Niger | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.