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

• Sponsor: Phillip Brian Smith (Other)
• Overall Status: Completed
• CT.gov ID: NCT00850122
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Prematurity	Drug: cefazolin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Cefazolin pharmacokinetics including half life, clearance, and volume of distribution [Dose 1 and Dose 4]

Secondary Outcome Measures

1. Safety [7 days following last dose of cefazolin]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phillip Brian Smith, Professor of Pediatrics, Duke University
• ClinicalTrials.gov Identifier: NCT00850122
• Other Study ID Numbers: Pro00012011; 1K23HD060040-01
• First Posted: Feb 24, 2009
• Last Update Posted: Sep 4, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Premature Birth; Cefazolin

Study Results

No Results Posted as of Sep 4, 2018