biostudies-literatureTurkova AUKRI MRC DfID Wellcome NIHR Joint Global Health TrialsMedical Research CouncilNational Institute for Health Research (NIHR)TB AllianceWellcome Trust911-922https://www.ebi.ac.uk/biostudies/studies/S-EPMC7612496biostudies-literatureUnknown386(10)<h4>Background</h4>Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen.<h4>Methods</h4>We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence],The New England journal of medicineShorter Treatment for Nonsevere Tuberculosis in African and Indian Children.PMC7612496MR/L004445/1MC_UU_00004/04206379/Z/17/ZMR/R007942/1MC_UU_12023/27MC_UU_12023/26Schaaf SSsenyonga MGie RSeddon JARevathy MLeBeau Kvan der Zalm MMCrook AMGrzemska MMcGowan CTeera JSwaminathan SWelch SBWills GWalker SMave VRohini SMwanakalanga HShingalili EMorrison JWalters EZyambo KChungu CKalumbi MMSeetha AOwen-Powell EKinikar AABanu PGibb DMTembo CBaskaran DShankar SWhittaker EMwinga AWobudeya EMulambo SVaishnavi SDarbyshire JSsengooba WFielding KMusoke PChoo LClayden PWorkman JNagarajan VSHINE Trial TeamRaichur PZulu SMboizi RBYadav KAarnoutse RHissar SMulenga VBhavani PKPrathiksha GAbdullah ANakalanzi STurkova AMukisa Williams CGuru KKinikar ASelvi RChipoya TGoussard PMwanyungwi HTapse DBaptiste DKumar MHesseling ACNansamba WKumar SLatha HChambela EHankombo JMBaldwin MRHoddinott GHanna LMary SSingh VGrandjean LNijampurkar ADonald PGunasundari ASpyer MLove-Koh Jvan Deventer AMangalambal GMalama SKapasa MRevill PKesavan ASane MLungu JAravind MAKunda SSupriya RRamesh KWills GHSekar LAnderson SMugyenyi PPeto TC Hesseling ABharathi SGopika SBalaji SGanesh JGraham SMZimba KMythily VChola DChelvi SBusinge GElilarasi SThomason MJMcIlleron HGomathi NSDemers AMKumar HChabala CGiranab HPalmer MJoseph BXavier DZimri WKhan SfalseShorter Treatment for Nonsevere Tuberculosis in African and Indian Children.<h4>Background</h4>Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen.<h4>Methods</h4>We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence],2022-01-01T00:00:00Z2022 Mar2025-04-19T12:54:09.399Z2025-04-19T12:54:09.399ZS-EPMC76124963526351710.1056/NEJMoa2104535