An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of
IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is
similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on
the basis of previous pediatric pharmacokinetic studies.
Phase:
Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:
Children's Hospital of Michigan Pediatric Pharmacology Research Units Network