Novel Triple-dose Tuberculosis Retreatment Regimen to Overcome Resistance Without Creating More in Niger

What this Trial Is About

This research aims to evaluate whether a high-dose first-line treatment is as safe as the standard dosing for patients previously treated for rifampicin-susceptible recurrent Tuberculosis (TB). This randomized clinical trial includes people with recurrent pulmonary TB to compare two regimens, focusing on safety and effectiveness in preventing resistance and relapse over time. The study has two stages: Stage 1 compares a standard 6-month regimen (6EHRZ) with a high-dose regimen (6EH³R³Z) that uses triple doses of rifampicin and isoniazid alongside pyrazinamide and ethambutol. If the high-dose regimen is not found non-inferior, the study continues with the standard regimen and an adapted intervention. Stage 2 shifts to an observational cohort using only the standard regimen due to safety concerns. Patients receive daily treatment under supervision with monthly clinic visits and liver function tests at set intervals. Participants are closely monitored during and after treatment, including regular checks for adverse effects, treatment response, and TB relapse through sputum tests at six months and one year post-treatment. Researchers track safety outcomes such as serious adverse events and liver toxicity, as well as bacterial effectiveness and resistance development, with follow-up lasting up to 18 months.

Novel Triple-dose Tuberculosis Retreatment Regimen