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An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants

Book Chapter

Smith, P. B.; Benjamin, D.; The Emmes Corporation (BPCA DCC)

Best Pharmaceuticals for Children Act (BPCA) Clinical Reports

Bethesda, MD



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.

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