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We characterize moxifloxacin population pharmacokinetics and QT interval prolongation and evaluate optimal dosing in children with RR-TB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Pharmacokinetic data were pooled from 2 observational studies in South African children with RR-TB routinely treated with oral moxifloxacin once daily. The population pharmacokinetics and Fridericia-corrected QT (QTcF)-interval prolongation were characterized in NONMEM. Pharmacokinetic simulations were performed to predict expected exposure and optimal weight-banded dosing.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eighty-five children contributed pharmacokinetic data (median [range] age of 4.6 [0.8\u201315] years); 16 (19%) were aged &amp;lt;2 years, and 8 (9%) were living with human immunodeficiency virus (HIV). The median (range) moxifloxacin dose on pharmacokinetic sampling days was 11 mg\/kg (6.1 to 17). Apparent clearance was 6.95 L\/h for a typical 16-kg child. Stunting and HIV increased apparent clearance. Crushed or suspended tablets had faster absorption. The median (range) maximum change in QTcF after moxifloxacin administration was 16.3 (\u201327.7 to 61.3) ms. No child had QTcF\u2005\u2265500 ms. The concentration\u2013QTcF relationship was nonlinear, with a maximum drug effect (Emax) of 8.80 ms (interindividual variability\u2005=\u20059.75 ms). Clofazimine use increased Emax by 3.3-fold. Model-based simulations of moxifloxacin pharmacokinetics predicted that current dosing recommendations are too low in children.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Moxifloxacin doses above 10\u201315 mg\/kg are likely required in young children to match adult exposures but require further safety assessment, especially when coadministered with other QT-prolonging agents.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab641","type":"journal-article","created":{"date-parts":[[2021,7,21]],"date-time":"2021-07-21T11:02:15Z","timestamp":1626865335000},"page":"1372-1381","source":"Crossref","is-referenced-by-count":32,"title":["Moxifloxacin Pharmacokinetics, Cardiac Safety, and Dosing for the Treatment of Rifampicin-Resistant Tuberculosis in Children"],"prefix":"10.1093","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0578-6554","authenticated-orcid":false,"given":"Kendra K","family":"Radtke","sequence":"first","affiliation":[{"name":"Department of Bioengineering and Therapeutic Sciences, University of California\u2013San Francisco, San Francisco, California, USA"}],"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, Tygerberg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J L","family":"Winckler","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather R","family":"Draper","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belen P","family":"Solans","sequence":"additional","affiliation":[{"name":"Department of Bioengineering and Therapeutic Sciences, University of California\u2013San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Thee","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa"},{"name":"Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charit\u00e9\u2014Universit\u00e4tsmedizin Berlin , Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louvina E","family":"van der Laan","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barend","family":"Fourie","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South 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