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

NCT ID: NCT00850122

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Sepsis; Prematurity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

cefazolin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 48 Hours
• Maximum Eligible Age: 120 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Phillip Brian Smith

OTHER

Sponsor Role: lead

Responsible Party

Phillip Brian Smith

Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Federal University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

1K23HD060040-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00012011

Identifier Type: -

Identifier Source: org_study_id