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Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants

Daniel Gonzalez1, Paula Delmore2, Barry T Bloom2

  • 1Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Antimicrobial Agents and Chemotherapy
|March 2, 2016
PubMed

Insights

Optimal clindamycin dosing for infant sepsis is unknown. New dosing regimens based on postmenstrual age (PMA) achieve effective drug concentrations against Staphylococcus aureus in neonates, with no reported adverse events.

Area of Science:

  • Pharmacology
  • Neonatal Medicine
  • Infectious Diseases

Background:

  • Methicillin-resistant Staphylococcus aureus (MRSA) is a significant cause of sepsis in infants.
  • Clindamycin exhibits activity against MRSA, but its optimal dosing in neonates remains undetermined.
  • Understanding clindamycin pharmacokinetics (PK) in infants is crucial for effective treatment.

Purpose of the Study:

  • To conduct a prospective pharmacokinetic and safety study of clindamycin in infants.
  • To determine optimal intravenous clindamycin dosing regimens for neonates.
  • To evaluate the association of patient factors with clindamycin PK parameters.

Main Methods:

  • Multicenter, prospective pharmacokinetic and safety study involving 62 infants.
  • Population pharmacokinetic analysis incorporating data from additional pediatric trials.
  • Analysis of factors including body weight, postmenstrual age (PMA), and plasma protein concentrations.

Main Results:

  • Postmenstrual age (PMA) and plasma protein concentrations significantly influenced clindamycin clearance and volume of distribution.
  • Clindamycin clearance reached 50% of adult values at a PMA of 39.5 weeks.
  • Simulated PMA-based dosing regimens (5-9 mg/kg every 8 hours) achieved target unbound concentrations against S. aureus in over 90% of infants.

Conclusions:

  • Established PMA-based intravenous clindamycin dosing regimens are effective and safe for infants.
  • These dosing strategies ensure adequate drug exposure to combat MRSA sepsis in neonates.
  • No adverse events were associated with clindamycin use in the study population.

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