Higher-Dose Tuberculosis Retreatment Regimen Tested in Niger
Tests a higher-dose tuberculosis drug regimen in people with recurrent, rifampicin-susceptible tuberculosis.
Plain-language title generated from the registry record
Registry title: Novel Triple-dose Tuberculosis Retreatment Regimen
Key facts
- Where
- Niamey, NigerSee the site
- Phase
- Phase 3
Where in Niger
- Damien FoundationNiamey, NigerTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Tropical Medicine, Belgium
- Trial code
- NCT04260477
- Record updated
- 13 April 2025
- Original description
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).Read full original descriptionShow less
Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger
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).
Inclusion: 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: 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; Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening; 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.