NCT01295606

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

December 7, 2010

Last Update Submit

December 12, 2011

Conditions

Prophylaxis

Keywords

cefazolinprophylaxispharmacokineticsnewborn

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of iv cefazolin in neonates

    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 Outcomes (1)

  • Optimalisation of cefazolin dose regimen during neonatal life

    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)

Study Arms (1)

Cefazolin, antibiotic prophylaxis

NO INTERVENTION

All included patients will received iv cefazolin

Drug: Cefazolin

Interventions

CefazolinDRUG

iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment

Also known as: Kefzol
Cefazolin, antibiotic prophylaxis

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • signed parental informed written consent
  • neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)

You may not qualify if:

  • known cefazolin intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elkayal O, Allegaert K, Spriet I, Smits A, Seghaye MC, Charlier C, Dreesen E. Population pharmacokinetics of cefazolin in maternal and umbilical cord plasma, and simulated exposure in term neonates. J Antimicrob Chemother. 2021 Nov 12;76(12):3229-3236. doi: 10.1093/jac/dkab329.

    PMID: 34499720DERIVED

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Karel Allegaert, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

February 14, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 13, 2011

Record last verified: 2010-12