NCT00850122

An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Phillip Brian Smith · Academic / Other
• Sex: All
• Age: 48 Hours – 120 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Prematurity

Interventions

Type	Name	Description
DRUG	cefazolin	Cefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2009-02-24
• Last updated: 2018-09-04

Locations

1 site across 1 country: Brazil