Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.

Journal Article (Journal Article;Multicenter Study)

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. (This study has been registered at under registration no. NCT01728363.).

Full Text

Duke Authors

Cited Authors

  • Gonzalez, D; Delmore, P; Bloom, BT; Cotten, CM; Poindexter, BB; McGowan, E; Shattuck, K; Bradford, KK; Smith, PB; Cohen-Wolkowiez, M; Morris, M; Yin, W; Benjamin, DK; Laughon, MM

Published Date

  • May 2016

Published In

Volume / Issue

  • 60 / 5

Start / End Page

  • 2888 - 2894

PubMed ID

  • 26926644

Pubmed Central ID

  • PMC4862454

Electronic International Standard Serial Number (EISSN)

  • 1098-6596

Digital Object Identifier (DOI)

  • 10.1128/AAC.03086-15


  • eng

Conference Location

  • United States