This trial is active, not recruiting.

Conditions sepsis, prematurity
Treatment cefazolin
Phase phase 1
Sponsor Phillip Brian Smith
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date July 2013
End date July 2016
Trial size 9 participants
Trial identifier NCT00850122, 1K23HD060040-01, Pro00012011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Dosage Number of Infants ≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6
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

Primary Outcomes

Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
time frame: Dose 1 and Dose 4

Secondary Outcomes

time frame: 7 days following last dose of cefazolin

Eligibility Criteria

Male or female participants up to 120 days old.

Inclusion Criteria: - < 28 weeks gestation at birth - > 48 hours and <121 days of age at the time of study drug administration - One of the following: - Suspected systemic infection - Receiving cefazolin for prophylaxis - Receiving cefazolin treatment of a systemic infection Exclusion Criteria: - History of anaphylaxis attributed to a β-lactam - Exposure to cefazolin in the month prior to study - Serum creatinine > 1.7 mg/dL

Additional Information

Official title An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Duke University.