Clindamycin pharmacokinetics and safety in preterm and term infants

Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 1 2016

Fingerprint

Clindamycin
Premature Infants
Pharmacokinetics
Safety
Methicillin-Resistant Staphylococcus aureus
Population
Staphylococcus aureus
Sepsis
Pediatrics

ASJC Scopus subject areas

  • Pharmacology
  • Infectious Diseases
  • Pharmacology (medical)

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

Clindamycin pharmacokinetics and safety in preterm and term infants. / Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee.

In: Antimicrobial Agents and Chemotherapy, Vol. 60, No. 5, 01.05.2016, p. 2888-2894.

Research output: Contribution to journalArticle

Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee 2016, 'Clindamycin pharmacokinetics and safety in preterm and term infants', Antimicrobial Agents and Chemotherapy, vol. 60, no. 5, pp. 2888-2894. https://doi.org/10.1128/AAC.03086-15
Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Clindamycin pharmacokinetics and safety in preterm and term infants. Antimicrobial Agents and Chemotherapy. 2016 May 1;60(5):2888-2894. https://doi.org/10.1128/AAC.03086-15
Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. / Clindamycin pharmacokinetics and safety in preterm and term infants. In: Antimicrobial Agents and Chemotherapy. 2016 ; Vol. 60, No. 5. pp. 2888-2894.
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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.",
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