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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 …
Footnotes
Review of article Turkova A, Wills GH, Wobudeya E, et al. Shorter treatment for nonsevere tuberculosis in African and Indian children. N Engl J Med 2022;386:911–922.
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Provenance and peer review Not commissioned; internally peer reviewed.