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Four months of tuberculosis (TB) treatment is non-inferior to the current 6-month treatment in drug-susceptible paediatric TB
  1. Graciaa Singhal1,
  2. Amanda Jane Friend2
  1. 1 Hull York Medical School, Hull, UK
  2. 2 Paediatrics, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK
  1. Correspondence to Graciaa Singhal, Hull York Medical School, Hull HU6 7RX, UK; graciaasinghal{at}outlook.com

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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 …

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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.

  • Twitter @graciaa_singhal, @the_learnaholic

  • Provenance and peer review Not commissioned; internally peer reviewed.