An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis; Prematurity
Intervention: cefazolin (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Duke University Overall contact:
P Brian Smith, MD MHS, Phone: 9196688951, Email: brian.smith@duke.edu
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 Details
Official title: An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
Secondary outcome: Safety
Eligibility
Minimum age: N/A.
Maximum age: 120 Days.
Gender(s): Both.
Criteria:
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
Locations and Contacts
P Brian Smith, MD MHS, Phone: 9196688951, Email: brian.smith@duke.edu
Federal University of Sao Paulo, Sao Paulo, Brazil
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: February 2009
Ending date: December 2009
Last updated: February 23, 2009
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