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

Sepsis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00850122
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date July 2013
Completion date July 2018
View Details
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