6/29/23, 11:41 PM SHINE Pathway Feedback Search Clinical Topics Home Studies SHINE SHINE Disease Disease Extrapulmonary tuberculosis Pulmonary tuberculosis Trial question Is 4 months antituberculosis treatment noninferior to 6 months treatment for children with non- severe tuberculosis? Study design Multi-center Open label RCT Population Characteristics of study participants 48.0% female N = 1204 52.0% male 1204 patients (583 female, 621 male) Inclusion criteria: children with non-severe, symptomatic, presumed drug-susceptible tuberculosis Key exclusion criteria: children with confirmed drug resistance; known exposure to an adult with any drug-resistant tuberculosis Interventions N=602 4 months treatment (first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the WHO for 16 weeks) N=602 6 months treatment (first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the WHO for 24 weeks) https://web.pathway.md/studies/recm9rDFN1vG3pQPK 1/2 6/29/23, 11:41 PM SHINE Pathway Primary outcome Treatment failure or disease recurrence at 72 weeks 3.0 % 3 3 2.3 % 1.5 % Difference not exceeding nonferiority margin 0.8 % 0.0 % 4 months treatment 6 months treatment Difference not exceeding nonferiority margin in treatment failure or disease recurrence at 72 weeks (3% vs. 3%; ARD -0.3, 95% CI -2.2 to 1.5) Safety outcomes No significant difference in grade 3 adverse events at 30 days post-treatment. Conclusion In children with non-severe, symptomatic, presumed drug-susceptible tuberculosis, 4 months treatment was noninferior to 6 months treatment with respect to treatment failure or disease recurrence at 72 weeks. Reference Anna Turkova, Genevieve H Wills, Eric Wobudeya et al. Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children. N Engl J Med. 2022 Mar 10;386(10):911-922. Open reference URL https://web.pathway.md/studies/recm9rDFN1vG3pQPK 2/2