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

NCT00850122 | Completed Phase 1

• 2 other identifiers: Pro000120111K23HD060040-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Prematurity

Outcome Measures

Primary Outcomes (1)

• Cefazolin pharmacokinetics including half life, clearance, and volume of distribution

  Dose 1 and Dose 4

Secondary Outcomes (1)

• Safety

  7 days following last dose of cefazolin

Study Arms (1)

Cefazolin

EXPERIMENTAL

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

Interventions

cefazolin DRUG

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

Cefazolin

Eligibility Criteria

• Age: 48 Hours - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 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

You may not qualify if:

• History of anaphylaxis attributed to a β-lactam
• Exposure to cefazolin in the month prior to study
• Serum creatinine \> 1.7 mg/dL

Sponsors & Collaborators

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

Study Sites (1)

Federal University of Sao Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Sepsis; Premature Birth

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: February 24, 2009
• Study Start: July 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

BR (1)