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

This study is not yet open for participant recruitment.

Verified February 2012 by Duke University

First Received on January 22, 2009. Last Updated on February 16, 2012 History of Changes

Sponsor:	Duke University
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):	Phillip Brian Smith, Duke University
ClinicalTrials.gov Identifier:	NCT00850122

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:

MedlinePlus related topics: Sepsis

Drug Information available for: Cefazolin Cefazolin sodium

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: P Brian Smith, MD MHS

9196688951

brian.smith@duke.edu

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Brazil
Federal University of Sao Paulo	Not yet recruiting
Sao Paulo, Brazil

Sponsors and Collaborators

Duke University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

No publications provided

Responsible Party:	Phillip Brian Smith, Associate Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier:	NCT00850122 History of Changes
Other Study ID Numbers:	Pro00012011, 1K23HD060040-01
Study First Received:	January 22, 2009
Last Updated:	February 16, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012