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Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children.

N Engl J Med

March 2022

From the Medical Research Council Clinical Trials Unit, University College London (A.T., G.H.W., L.C., K.L., M.J.T., D.M.G., A.M.C.), and the Department of Infectious Diseases, Imperial College London (J.A.S.), London, the Centre for Health Economics, University of York, York (J.L.-K.), and the Department of Paediatrics, Birmingham Chest Clinic and Heartlands Hospital, University Hospitals Birmingham, Birmingham (S.B.W.) - all in the United Kingdom; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda (E.W., P.M., R.B.M.); University Teaching Hospital, Lusaka, Zambia (C.C., V. Mulenga, M.K.); Desmond Tutu TB Centre, the Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch (M.P., M.M.Z., A.-M.D., J.A.S., A.C.H.), and the Division of Clinical Pharmacology, University of Cape Town, Cape Town (H.M.) - both in South Africa; B.J. Medical College, Pune (A.K., V. Mave, P.R.), and the National Institute for Research in Tuberculosis, Chennai (S.H., B.J., P.K.B.) - both in India; Radboud University Medical Center, Nijmegen, the Netherlands (R.A.); the Centre for International Child Health, Department of Paediatrics, University of Melbourne, and Murdoch Children's Research Institute, Royal Children's Hospital - both in Melbourne, VIC, Australia (S.M.G.); and the International Union against Tuberculosis and Lung Disease, Paris (S.M.G.).

Background: Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen.

Methods: 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.

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