ProphylaxisPhase 4NCT01295606
Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
A Phase 4 study testing Cefazolin in people with Prophylaxis, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Prophylaxis
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- signed parental informed written consent
- neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)
Who cannot join
- known cefazolin intolerance
About this study
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
Read the 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.
- Conditions
- Prophylaxis
- Being tested
- Cefazolin
- Keywords
- cefazolin, prophylaxis, pharmacokinetics, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called Kefzol
iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin, antibiotic prophylaxis | No intervention | All included patients will received iv cefazolin Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of iv cefazolin in neonates
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProphylaxisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Allegaert, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295606
- Sponsor's protocol ID
- S52907
- Other IDs
- 2010-024319-15
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2010
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34499720
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
- ClinicalTrials.gov ID
- NCT01295606
- Acronym / sponsor ID
- S52907
- Conditions
- Prophylaxis
- Keywords
- cefazolin, prophylaxis, pharmacokinetics, newborn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin, antibiotic prophylaxis | No intervention | Drug: CefazolinAll included patients will received iv cefazolin |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- signed parental informed written consent
- neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)
Key exclusion criteria (1 listed)
- known cefazolin intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinAlso: Kefzoliv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment | Drug | Cefazolin, antibiotic prophylaxis |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 34499720Elkayal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Allegaert, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin in people with Prophylaxis, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01295606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.