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Cefazolin Pharmacokinetics: Elimination Clearance in Neonates

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ClinicalTrials.gov Identifier: NCT01295606
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Prophylaxis Drug: Cefazolin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
Study Start Date : February 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295606

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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01295606     History of Changes
Other Study ID Numbers: S52907
2010-024319-15 ( EudraCT Number )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2010

Keywords provided by Universitaire Ziekenhuizen Leuven:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents