{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T19:19:30Z","timestamp":1787858370951,"version":"build-2784847793"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,10,19]],"date-time":"2021-10-19T00:00:00Z","timestamp":1634601600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD069175"],"award-info":[{"award-number":["R01HD069175"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["206379\/Z\/17\/Z"],"award-info":[{"award-number":["206379\/Z\/17\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"name":"PanACEA"},{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","award":["TRIA2015-1102"],"award-info":[{"award-number":["TRIA2015-1102"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]},{"name":"SA-MRC"},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI068634"],"award-info":[{"award-number":["UM1 AI068634"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI068636,"],"award-info":[{"award-number":["UM1 AI068636,"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI106701"],"award-info":[{"award-number":["UM1 AI106701"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In 2010, the World Health Organization (WHO) revised dosing guidelines for treatment of childhood tuberculosis. Our aim was to investigate first-line antituberculosis drug exposures under these guidelines, explore dose optimization using the current dispersible fixed-dose combination (FDC) tablet of rifampicin\/isoniazid\/pyrazinamide; 75\/50\/150\u00a0mg, and suggest a new FDC with revised weight bands.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Children with drug-susceptible tuberculosis in Malawi and South Africa underwent pharmacokinetic sampling while receiving first-line tuberculosis drugs as single formulations according the 2010 WHO recommended doses. Nonlinear mixed-effects modeling and simulation was used to design the optimal FDC and weight-band dosing strategy for achieving the pharmacokinetic targets based on literature-derived adult AUC0-24h for rifampicin (38.7\u201372.9), isoniazid (11.6\u201326.3), and pyrazinamide (233\u2013429 mg\u2005\u2219\u2005h\/L).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 180 children (42% female; 13.9% living with human immunodeficiency virus [HIV]; median [range] age 1.9 [0.22\u201312] years; weight 10.7 [3.20\u201328.8] kg) were administered 1, 2, 3, or 4 FDC tablets (rifampicin\/isoniazid\/pyrazinamide 75\/50\/150\u00a0mg) daily for 4\u20138, 8\u201312, 12\u201316, and 16\u201325\u00a0kg weight bands, respectively. Rifampicin exposure (for weight and age) was up to 50% lower than in adults. Increasing the tablet number resulted in adequate rifampicin but relatively high isoniazid and pyrazinamide exposures. Administering 1, 2, 3, or 4 optimized FDC tablets (rifampicin\/isoniazid\/pyrazinamide 120\/35\/130\u00a0mg) to children\u2005&amp;lt;\u20056, 6\u201313, 13\u201320. and 20\u201325\u00a0kg, and 0.5 tablet in\u2005&amp;lt;\u20053-month-olds with immature metabolism, improved exposures to all 3 drugs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Current pediatric FDC doses resulted in low rifampicin exposures. Optimal dosing of all drugs cannot be achieved with the current FDCs. We propose a new FDC formulation and revised weight bands.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab908","type":"journal-article","created":{"date-parts":[[2021,10,16]],"date-time":"2021-10-16T10:53:35Z","timestamp":1634381615000},"page":"141-151","source":"Crossref","is-referenced-by-count":32,"title":["Optimizing Dosing and Fixed-Dose Combinations of Rifampicin, Isoniazid, and Pyrazinamide in Pediatric Patients With Tuberculosis: A Prospective Population Pharmacokinetic Study"],"prefix":"10.1093","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7494-079X","authenticated-orcid":false,"given":"Paolo","family":"Denti","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5769-8150","authenticated-orcid":false,"given":"Roeland E","family":"Wasmann","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annelies","family":"van Rie","sequence":"additional","affiliation":[{"name":"Family Medicine and Population Health, Faculty of Medicine, University of Antwerp , Antwerp , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jana","family":"Winckler","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrie","family":"Bekker","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Rabie","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health and FAMily Centre for Research with Ubuntu (FAMCRU) Stellenbosch University and Tygerberg Hospital , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anneke C","family":"Hesseling","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louvina E","family":"van der Laan","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town , South Africa"},{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Gonzalez-Martinez","sequence":"additional","affiliation":[{"name":"Malawi-Liverpool-Wellcome Trust Clinical Research Programme , Blantyre , Malawi \/Liverpool School of Tropical Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather J","family":"Zar","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health, Red Cross War Memorial Children\u2019s Hospital, and SA-MRC Unit on Child & Adolescent Health, University of Cape Town , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerry","family":"Davies","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool , Liverpool , United Kingdom"},{"name":"Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool , Liverpool , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9070-8699","authenticated-orcid":false,"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elin M","family":"Svensson","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center , Nijmegen , The Netherlands"},{"name":"Department of Pharmacy, Uppsala University , Uppsala , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen M","family":"McIlleron","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town , South Africa"},{"name":"Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town , Cape Town , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,10,19]]},"reference":[{"key":"2022082502581754400_CIT0001","author":"World Health Organization.","year":"2020"},{"key":"2022082502581754400_CIT0002","first-page":"S407","article-title":"LB-2056-24 Shorter treatment for minimal tuberculosis in children: main findings from the SHINE trial","volume":"24","author":"Wobudeya","year":"2020","journal-title":"Int J Tuberc Lung Dis"},{"key":"2022082502581754400_CIT0003","doi-asserted-by":"crossref","first-page":"614","DOI":"10.1136\/adc.2004.052175","article-title":"Isoniazid pharmacokinetics in children treated for respiratory tuberculosis","volume":"90","author":"Schaaf","year":"2005","journal-title":"Arch Dis 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