An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
This is a phase I open label multi-dose study to investigative the pharmacokinetics and
safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected
sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2)
>28 days of age and <121 days of age. The study requires administration of the study drug
over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained
over the 2 days of drug administration. The risks are reasonable vs. the benefits and have
been minimized appropriately. There may be benefit to the subjects (administration of
empirical antimicrobial therapy), and information from the study may benefit a large number
of other infants in whom the drug is currently being administered despite the lack of PK data
in this population.
Phase:
Phase 1
Details
Lead Sponsor:
Phillip Brian Smith
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)