- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295606
Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure
To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed
Study Overview
Detailed Description
Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin administration in neonates admitted in the neonatal intensive care unit, University Hospitals Leuven, Belgium.
Patients will be included after signed informed consent of the parents.
Our aim is to include 40 neonates. Cefazolin has been selected for this study as it is routinely administered in neonates undergoing invasive procedures in our unit. At this stage, we only have the intention to document pharmacokinetics and covariates based on the current clinical practice and therefore will not interfere with either clinical indication, or with dosing as prescribed by the attending physician.
Drug administration and collection of samples will be obtained to the current clinical and nursing standard procedures.
Routine clinical care for scheduled invasive procedures in neonates in our unit is intravenous administration of cefazolin as follows:
- 50 mg/kg, 3 times a day
- an extra dose of 50mg/kg is given after 3 hours for operations longer than 3 h
- each time one dose/day is excluded for neonates with body weight <2000 g and postnatal age (PNA) <7 days,
- for invasive operations (e.g. open-heart surgery, laparotomy) the prophylactic administration of cefazolin may be continued for 3-5 days following the completion of surgery.
The antibiotic agent should be administered 30 minutes to 1 hour prior to the start of surgery so that adequate antibiotic levels. Cefazolin is administered to the neonate, through a peripherally inserted venous catheter, during 30 minutes.
Blood will be collected in heparinised tubes through an indwelling arterial line, or deep venous access, always when other routine blood samples are collected for clinical purposes (pO2, pCO2, pH).
Urine samples will be collected through a bladder catheter in patients in whom a bladder catheter is available for clinical indications.
Pharmacokinetic analysis A population pharmacokinetics approach will be used, hereby comparing the data on PK already reported in adults or older children and the newly collected data during neonatal life.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- signed parental informed written consent
- neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)
Exclusion Criteria:
- known cefazolin intolerance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Cefazolin, antibiotic prophylaxis
All included patients will received iv cefazolin
|
iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of iv cefazolin in neonates
Time Frame: up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)
|
up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Optimalisation of cefazolin dose regimen during neonatal life
Time Frame: up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)
|
up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karel Allegaert, MD PhD, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S52907
- 2010-024319-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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