Four months of tuberculosis (TB) treatment is non-inferior to the current 6-month treatment in drug-susceptible paediatric TB

Study design Design: An open-label, non-inferiority, randomised controlled trial. Allocation: 1:1 allocation, stratified by age, HIV status, treating centre and ethambutol use. Blinding: Single blinding of diagnosis and endpoint tuberculosis (TB) review committees. Study question Setting: Uganda, Zambia, South Africa and India. Patients: 1204 children (aged <16 years) with symptomatic, non-severe, smear-negative TB due to the start of first-line treatment. Intervention: 8 weeks of standard treatment as per local guidelines, followed by isoniazid/rifampicin for 16 weeks in the control arm, and 8 weeks in the intervention arm. Primary outcomes: ‘Unfavourable’ status by 72 weeks, including treatment failure, loss to follow-up or death. A modified intention-to-treat analyses was carried out. Secondary outcomes: Adverse event of grade ≥3 and economic analyses to estimate costs and health outcomes. Follow-up: 72 weeks (18 months) from the start of treatment. Main results The % of participants that had a primary-outcome event was 3% in both...
Source: Archives of Disease in Childhood - Education and Practice - Category: Pediatrics Authors: Tags: Picket Key publications in paediatrics: Picket Source Type: research