Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Studying the safety and pharmacokinetics of three different antibiotics for treatment of staphylococcal infections in term and premature infants.

This study evaluated the pharmacokinetics and safety of 3 antistaphylococcal antibiotics in term and premature infants. Up to 32 infants were enrolled for each antibiotic. The study was open to children of both sexes and all racial and ethnic groups. The study lasted approximately 18 months; each infant in the study participated for up to 10 days.

Summary

In premature infants, 70% of late-onset infection in the neonatal intensive care unit is due to staphylococcal species. The majority of coagulase-negative Staphylococcus isolates (95%) and Staphylococcus aureus isolates (40%) are methicillin-resistant. Infants with these infections have lengthy hospitalizations and an increased risk of septic shock, severe necrotizing pneumonia, and neurodevelopmental impairment, as well as a high risk of mortality (up to 40%). Rifampin, clindamycin, and ticarcillin-clavulanate all have activity against staphylococcal species. However, the correct dosing and safety of these antibiotics had not been established in all infant populations.

This study determined the pharmacokinetics of rifampin, clindamycin, and ticarcillin-clavulanate in term and premature infants. We measured the levels of each antibiotic in each infant, thereby helping to determine the best dose of these drugs to treat staphylococcal infections in these patients. It is likely that the drugs behave differently in premature infants than they do in older children and adults due to the immaturity of their metabolic and kidney pathways; thus, identifying the correct dosages represents a critical public health need. We enrolled up to 32 infants for each drug. The drugs were given over 2–4 days, and the infants were monitored for another 7 days for any drug side effects.

OVERVIEW

Status:
Completed

ClinicalTrials.gov identifier:
NCT01728363

Principal Investigator:
Matthew Laughon, MD, MPH
University of North Carolina
Chapel Hill, NC

NEWS

  • PTN study contributes to successful treatment of MRSA abscess in preterm infant November 7, 2017 Early this summer, Lucas,* a one-month-old infant born 9 weeks prematurely, was receiving routine respiratory support in the neonatal intensive care unit at the University of North Carolina Children’s Hospital when he suddenly developed a dangerous neck abscess. Upon testing, the infection was found to be caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria. Staphylococcus infections ...
  • The PTN anti-staph trial marks its first enrollment February 12, 2013 Dr. Barry Bloom and Ms. Paula Delmore at Wesley Medical Center in Wichita, Kansas, have enrolled the first baby into the Pharmacokinetics of Anti-staphylococcal Antibiotics in Infants trial. The infant—born at 24 weeks gestation and now 52 days old—is receiving clindamycin, one of three anti-staphylococcal antibiotics routinely used in preemies to treat staphylococcal infections. Seventy percent ...