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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Prematurity
• Intervention / Treatment: Drug: cefazolin

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution	Dose 1 and Dose 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	7 days following last dose of cefazolin

Collaborators and Investigators

• Sponsor: Phillip Brian Smith
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 24, 2009

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: Pro00012011; 1K23HD060040-01 (U.S. NIH Grant/Contract)