Novel Triple-dose Tuberculosis Retreatment Regimen
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).
| Condition(s) | Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 | 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 prote |
| Sex | All |
| Lead sponsor | Institute of Tropical Medicine, Belgium |
| Locations | Niamey, Niger |
| Start date | 2021-03-01 |
| NCT ID | NCT04260477 |
| Official listing | https://clinicaltrials.gov/study/NCT04260477 |