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Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.

Author information

1
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
2
Department of Neonatology, Wesley Medical Center, Wichita, Kansas, USA.
3
Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
4
Department of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, Indiana, USA.
5
Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts, USA.
6
Department of Pediatrics, University of Texas Medical Branch, Galveston, Texas, USA.
7
Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
8
Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
9
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
10
Emmes Corporation, Rockville, Maryland, USA.
11
Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA matt_laughon@med.unc.edu.

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

PMID:
26926644
PMCID:
PMC4862454
DOI:
10.1128/AAC.03086-15
[Indexed for MEDLINE]
Free PMC Article

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