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Cefazolin Pharmacokinetics: Elimination Clearance in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01295606
First received: December 7, 2010
Last updated: December 12, 2011
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Prophylaxis
Drug: Cefazolin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cefazolin Pharmacokinetics: Elimination Clearance in Neonates

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Cefazolin, antibiotic prophylaxis
All included patients will received iv cefazolin
Drug: Cefazolin
iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
Other Name: Kefzol

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295606

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Karel Allegaert, MD PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01295606     History of Changes
Other Study ID Numbers: S52907, 2010-024319-15
Study First Received: December 7, 2010
Last Updated: December 12, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
cefazolin
prophylaxis
pharmacokinetics
newborn

Additional relevant MeSH terms:
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014