Clindamycin pharmacokinetics and safety in preterm and term infants

Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing in this population is unknown. We performed a multicenter, prospective pharmacokinetic (PK) and safety study of clindamycin in infants. We analyzed the data using a population PK analysis approach and included samples from two additional pediatric trials. Intravenous data were collected from 62 infants (135 plasma PK samples) with postnatal ages of < 121 days (median [range] gestational age of 28 weeks [23 to 42] and postnatal age of 17 days [1 to 115]). In addition to body weight, postmenstrual age (PMA) and plasma protein concentrations (albumin and alpha-1 acid glycoprotein) were found to be significantly associated with clearance and volume of distribution, respectively. Clearance reached 50% of the adult value at PMA of 39.5 weeks. Simulated PMA-based intravenous dosing regimens administered every 8 h (≤32 weeks PMA, 5 mg/kg; 32 to 40 weeks PMA, 7 mg/kg; > 40 to 60 weeks PMA, 9 mg/kg) resulted in an unbound, steady-state concentration at half the dosing interval greater than a MIC for S. aureus of 0.12 μg/ml in >90% of infants. There were no adverse events related to clindamycin use.

Original languageEnglish (US)
Pages (from-to)2888-2894
Number of pages7
JournalAntimicrobial agents and chemotherapy
Volume60
Issue number5
DOIs
StatePublished - May 2016

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ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee (2016). Clindamycin pharmacokinetics and safety in preterm and term infants. Antimicrobial agents and chemotherapy, 60(5), 2888-2894. https://doi.org/10.1128/AAC.03086-15