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.

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Key information

Conditions

Sepsis Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

48 hour–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Federal University of Sao Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

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

Primary outcomes

Cefazolin pharmacokinetics including half life, clearance, and volume of distribution

Time frame: Dose 1 and Dose 4

Secondary outcomes

Safety

Time frame: 7 days following last dose of cefazolin

Sponsors and collaborators

Lead sponsor

Phillip Brian Smith

Other

Collaborators

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

Registry information

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Feb 24, 2009
Registry last updated: Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed