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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00850122
First received: January 22, 2009
Last updated: July 1, 2014
Last verified: July 2014

January 22, 2009
July 1, 2014
July 2013
December 2014   (final data collection date for primary outcome measure)
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution [ Time Frame: Dose 1 and Dose 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00850122 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 7 days following last dose of cefazolin ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sepsis
  • Prematurity
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

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

Intervention: Drug: cefazolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
January 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
up to 120 Days
No
Contact: P Brian Smith, MD MHS 9196688951 brian.smith@duke.edu
Brazil
 
NCT00850122
Pro00012011, 1K23HD060040-01
No
Phillip Brian Smith, Duke University Medical Center
Phillip Brian Smith
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Duke University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP