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Safety, Effectiveness and Exposure-response of Micafungin in Infants

Application of an Established Pharmacokinetics Model to Electronic Health Records

Rivera-Chaparro, Nazario D., MD*,†; Ericson, Jessica, MD, MPH; Wu, Huali, PhD*; Smith, P. Brian, MD, MPH, MHS*,†; Clark, Reese H., MD§; Benjamin, Daniel K. Jr., MD, PhD*,†; Cohen-Wolkowiez, Michael, MD, PhD*,†; Greenberg, Rachel G., MD, MB, MHS*,†

The Pediatric Infectious Disease Journal: February 2019 - Volume 38 - Issue 2 - p e26–e28
doi: 10.1097/INF.0000000000002045
Antimicrobial Reports
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Micafungin is used off-label in the United States to treat invasive candidiasis in neonates. We used an established pharmacokinetic model to determine micafungin exposures for 46 courses in 39 hospitalized infants. In this small cohort of infants, micafungin exposure was not associated with laboratory markers of liver toxicity, death or failure of microbiologic clearance.

From the *Duke Clinical Research Institute

Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina

Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania

§Pediatrix Medical Group, Inc., Sunrise, Florida.

Accepted for publication February 28, 2018.

N.D.R.-C. is supported by training grant T32 from the National Institute of Child Health and Human Development (T32GM086330-06). R.G.G. receives salary support from the National Institutes of Health (HHSN 275201000003I, HHSN272201300017I) and from the US Food and Drug Administration (HHSF223201610082C). M.C.-W. receives support for research from the National Institutes of Health (1R01-HD076676-01A1), National Institute of Allergy and Infectious Diseases (HHSN272201500006I, HHSN272201300017I), National Institute of Child Health and Human Development (HHSN275201000003I), Biomedical Advanced Research and Development Authority (HHSO100201300009C) and industry for drug development in adults and children (www.dcri.duke.edu/research/coi.jsp). D.K.B. receives support from the National Institutes of Health (award 2K24HD058735-06), National Institute of Child Health and Human Development (HHSN275201000003I), National Institute of Allergy and Infectious Diseases (HHSN272201500006I), Environmental Influences on Child Health Outcomes Program (1U2COD023375-01) and National Center for Advancing Translational Sciences (1U24TR001608-01); he also receives research support from Cempra Pharmaceuticals (subaward to HHSO100201300009C) and industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). P.B.S. receives salary support for research from the NIH (NIH-1R21HD080606-01A1), the National Institute for Child Health and Human Development (NICHD; HHSN275201000003I) and industry for drug development in adults and children (www.dcri.duke.edu/research/coi.jsp). H.W. receives salary support for research from the National Institutes of Health Clinical and Translational Science Award (5UL1TR001117-05). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR001117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

The authors have no conflicts of interest to disclose.

Address for correspondence: Michael Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705. Email: michael.cohenwolkowiez@duke.edu.

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