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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850122
• Other study ID #: Pro00012011
• Secondary ID: 1K23HD060040-01
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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 ß-lactam

• Exposure to cefazolin in the month prior to study

• Serum creatinine > 1.7 mg/dL

Related Conditions & MeSH terms

• Prematurity
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Phillip Brian Smith	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cefazolin pharmacokinetics including half life, clearance, and volume of distribution		Dose 1 and Dose 4
Secondary	Safety		7 days following last dose of cefazolin