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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. 1Hull York Medical School, Hull, UK
  2. 2Paediatrics, 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.