NCT04260477 Novel Triple-dose Tuberculosis Retreatment Regimen
| NCT ID | NCT04260477 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institute of Tropical Medicine, Belgium |
| Condition | Multidrug-resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2025-06 |
Trial Parameters
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Brief 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).
Eligibility Criteria
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