An open label study to describe the pharmacokinetics of acyclovir in premature infants

An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four g...

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Bibliographic Details
Main Authors: Smith, P. Brian, Benjamin, Daniel K. (Author)
Corporate Author: Eunice Kennedy Shriver National Institute of Child Health and Human Development (U.S.)
Format: eBook
Language:English
Published: Bethesda (MD) National Institute of Child Health and Human Development (US) 2017, 2017
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
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100 1 |a Smith, P. Brian 
245 0 0 |a An open label study to describe the pharmacokinetics of acyclovir in premature infants  |h Elektronische Ressource  |c principal Investigators, P. Brian Smith, Danny Benjamin 
246 3 1 |a BPCA Protocol NICHD-2011-ACY01 (Acyclovir) 
260 |a Bethesda (MD)  |b National Institute of Child Health and Human Development (US)  |c 2017, 2017 
300 |a 1 PDF file (65 pages)  |b illustrations 
700 1 |a Benjamin, Daniel K.  |e [author] 
710 2 |a Eunice Kennedy Shriver National Institute of Child Health and Human Development (U.S.) 
041 0 7 |a eng  |2 ISO 639-2 
989 |b NCBI  |a National Center for Biotechnology Information 
500 |a Proprietary information in this document has been redacted. - "Clinical study report." 
856 4 0 |u https://www.ncbi.nlm.nih.gov/books/NBK556632  |3 Volltext 
082 0 |a 610 
520 |a An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four groups, with GA 23-42 weeks and PNA up to 60 days; version 2.0 (n=19) included three groups, with GA 23-34 weeks and PNA <45 days. Acyclovir was administered every 8-12 hours for up to 3 days and was well tolerated. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program. Biospecimens were collected but are not currently available