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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00850122
First received: January 22, 2009
Last updated: February 11, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Sepsis
Prematurity
Drug: cefazolin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cefazolin pharmacokinetics including half life, clearance, and volume of distribution [ Time Frame: Dose 1 and Dose 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 7 days following last dose of cefazolin ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: July 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850122

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Phillip Brian Smith
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Responsible Party: Phillip Brian Smith, Associate Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00850122     History of Changes
Other Study ID Numbers: Pro00012011  1K23HD060040-01 
Study First Received: January 22, 2009
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016