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

Phase 1

Completed

• Conditions: Sepsis; Prematurity
• Interventions: Drug: cefazolin

• Registration Number: NCT00850122
• Lead Sponsor: Phillip Brian Smith

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Study Start: 2013-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cefazolin	cefazolin	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

Primary Outcome Measures

Name	Time	Method
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution	Dose 1 and Dose 4

Secondary Outcome Measures

Name	Time	Method
Safety	7 days following last dose of cefazolin

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil