Infection, BacterialNCT05200975
Target Attainment of Cefuroxim
A study testing Venapunction in people with Infection, Bacterial and Kinesics, run by Noordwest Ziekenhuisgroep at 1 site in Netherlands.
Trial summary
SUMMARY Rationale: Optimal antibiotic dosing in patients with bacterial infections is of high importance. Underdosing can lead to treatment failure and can promote emergence of antimicrobial resistance, while overdosing may lead to (harmful) side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial, Kinesics
- What is being tested?
- Venapunction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving cefuroxime therapy intravenous (iv) as part of standard care
- Age ≥ 18 years
- Admitted to a general ward of Noordwest Ziekenhuisgroep - location Alkmaar
- Informed consent is obtained
Who cannot join
- Mentally incapacitated patients, i.e. a minor or legally incompetent adult
- Renal replacement therapy during treatment with cefuroxime
- Patients admitted to the intensive care unit (ICU)
- Severely burned patients, defined as a burned surface ≥ 10%
- Patients with cystic fibrosis
- Informed consent is not obtained
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815JD
Saskia E Zieck, MSc, 0031880857476, se.zieck@nwz.nl
Ingrid M van Haelst, PhD, +31880853571, i.van.haelst@nwz.nl
About this study
Official title: Pharmacokinetic and Pharmacodynamic Target Attainment of Cefuroxime in Adult Patients on General Wards With Different Degrees of Renal Function: a Prospective Observational Cohort Study
SUMMARY Rationale: Optimal antibiotic dosing in patients with bacterial infections is of high importance. Underdosing can lead to treatment failure and can promote emergence of antimicrobial resistance, while overdosing may lead to (harmful) side effects. The antibiotic cefuroxime is a second-generation cephalosporin and is frequently used in hospitalized patients. Cefuroxime exhibits, like other cephalosporins, time-dependent killing. The pharmacodynamic target can therefore be best described as the percentage of the dosing interval that the serum concentration remains above the minimum inhibitory concentration (MIC) of the bacteria (T>MIC). Attaining the pharmacokinetic-pharmacodynamic (PK-PD) target of 50%T>MIC is associated with antimicrobial therapeutic efficacy of cefuroxime.
Because cefuroxime is almost exclusively excreted through the kidneys, dose reduction of cefuroxime for patients with renal impairment (eGFR<30ml/min/1.73m2) is standard of care. No prospective evidence exists that currently guideline-recommended cefuroxime dosing regimens result in at least 50%T>MIC in adult patients on general wards, especially not in patients with renal impairment receiving a reduced dose of cefuroxime.
Read more
Objective: To investigate whether the PK-PD target of cefuroxime (50%T>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of cefuroxime. Study design: Observational, prospective single center cohort study Study population: Adult patients (age ≥ 18 years) on general wards of Noordwest Ziekenhuisgroep (NWZ) receiving cefuroxime as part of standard care.
Intervention: Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Main study parameters: Percentage of patients attaining the cefuroxime PK-PD target of 50%T>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks imposed by participation are considered negligible. Three venapunctures, obtaining a maximum of 18 ml venous blood are not expected to cause AEs or SAEs. Participation itself does not bring any benefit as cefuroxime treatment is part of standard care, but the group related benefit could be significant. With the results of this study, current recommended cefuroxime dosing regimens are prospectively validated or an advice to reconsider current guidelines will be obtained.
- Conditions
- Infection, Bacterial, Kinesics
- Being tested
- Venapunction
- Keywords
- cefuroxim, renal function, target attainment, infectious disease
- Medical subject headings
- Bacterial Infections, Kinesics, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenapunctionDiagnostic test
Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
| Study group | Role | What they receive |
|---|---|---|
| Adequate renal function | Other | Patients with adequate renal function (egfr>30ml/min) receiving a regular cefuroxime dose Receives: Diagnostic Test: Venapunction |
| Impaired renal function | Other | Patients with impaired renal function (egfr<30ml/min) receiving a guideline recommended reduced dose Receives: Diagnostic Test: Venapunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Attainment
Main study parameter is the percentage of the study population attaining the target of 50%T>MIC within the first 24hrs of treatment. To calculate this endpoint cefuroxime concentrations and MIC-values will be obtained.
Measured: 0-24hours after treatment initiation
Secondary outcomes (1)
Target Attainment
Secondary study parameter is the percentage of the study population attaining the target of 50%T>MIC within the first 48hrs of treatment. To calculate this endpoint cefuroxime concentrations and MIC-values will be obtained.
Measured: 0-48hours after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Percentage of patients attaining the cefuroxime PK-PD target of 50%T\>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noordwest Ziekenhuisgroep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia E. Zieck, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200975
- Sponsor's protocol ID
- NL78342.029.21
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Target Attainment of Cefuroxime in Adult Patients on General Wards With Different Degrees of Renal Function: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05200975
- Acronym / sponsor ID
- NL78342.029.21
- Conditions
- Infection, Bacterial, Kinesics
- Keywords
- cefuroxim, renal function, target attainment, infectious disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Noordwest ZiekenhuisgroepUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- 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.
SUMMARY Rationale: Optimal antibiotic dosing in patients with bacterial infections is of high importance. Underdosing can lead to treatment failure and can promote emergence of antimicrobial resistance, while overdosing may lead to (harmful) side effects. The antibiotic cefuroxime is a second-generation cephalosporin and is frequently used in hospitalized patients. Cefuroxime exhibits, like other cephalosporins, time-dependent killing. The pharmacodynamic target can therefore be best described as the percentage of the dosing interval that the serum concentration remains above the minimum inhibitory concentration (MIC) of the bacteria (T>MIC). Attaining the pharmacokinetic-pharmacodynamic (PK-PD) target of 50%T>MIC is associated with antimicrobial therapeutic efficacy of cefuroxime.
Because cefuroxime is almost exclusively excreted through the kidneys, dose reduction of cefuroxime for patients with renal impairment (eGFR<30ml/min/1.73m2) is standard of care. No prospective evidence exists that currently guideline-recommended cefuroxime dosing regimens result in at least 50%T>MIC in adult patients on general wards, especially not in patients with renal impairment receiving a reduced dose of cefuroxime.
Objective: To investigate whether the PK-PD target of cefuroxime (50%T>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of cefuroxime. Study design: Observational, prospective single center cohort study Study population: Adult patients (age ≥ 18 years) on general wards of Noordwest Ziekenhuisgroep (NWZ) receiving cefuroxime as part of standard care.
Intervention: Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Main study parameters: Percentage of patients attaining the cefuroxime PK-PD target of 50%T>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks imposed by participation are considered negligible. Three venapunctures, obtaining a maximum of 18 ml venous blood are not expected to cause AEs or SAEs. Participation itself does not bring any benefit as cefuroxime treatment is part of standard care, but the group related benefit could be significant. With the results of this study, current recommended cefuroxime dosing regimens are prospectively validated or an advice to reconsider current guidelines will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Percentage of patients attaining the cefuroxime PK-PD target of 50%T>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose.
| Arm | Type | Receives |
|---|---|---|
| Adequate renal function | Other | Diagnostic Test: VenapunctionPatients with adequate renal function (egfr>30ml/min) receiving a regular cefuroxime dose |
| Impaired renal function | Other | Diagnostic Test: VenapunctionPatients with impaired renal function (egfr<30ml/min) receiving a guideline recommended reduced dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving cefuroxime therapy intravenous (iv) as part of standard care
- Age ≥ 18 years
- Admitted to a general ward of Noordwest Ziekenhuisgroep - location Alkmaar
- Informed consent is obtained
Key exclusion criteria (6 listed)
- Mentally incapacitated patients, i.e. a minor or legally incompetent adult
- Renal replacement therapy during treatment with cefuroxime
- Patients admitted to the intensive care unit (ICU)
- Severely burned patients, defined as a burned surface ≥ 10%
- Patients with cystic fibrosis
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 |
|---|---|---|
| VenapunctionThree venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total. | Diagnostic test | Adequate renal function, Impaired renal function |
Primary outcome
Target Attainment
Time frame: 0-24hours after treatment initiation
Main study parameter is the percentage of the study population attaining the target of 50%T>MIC within the first 24hrs of treatment. To calculate this endpoint cefuroxime concentrations and MIC-values will be obtained.
1 secondary outcome
Target Attainment
Time frame: 0-48hours after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Infection, Bacterial
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venapunction in people with Infection, Bacterial and Kinesics, run by Noordwest Ziekenhuisgroep at 1 site in Netherlands.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saskia E Zieck, MSc (0031880857476, se.zieck@nwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Attainment (time frame: 0-24hours after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.