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).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
STAGE 1:number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment
Timeframe: 18 months
STAGE 2: Describe bacterial effectiveness
Timeframe: 18 months
STAGE 2: Describe acquired resistance
Timeframe: 18 months