Pharmacokinetic and pharmacodynamic target attainment of cefuroxime in adult patients on general wards with different degrees of renal function: a prospective observational cohort study

Pharmacokinetic and pharmacodynamic target attainment of cefuroxime in adult patients on general wards with different degrees of renal function: a prospective observational cohort study - Target attainment of cefuroxime

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52078

Enrollment

Registered

2021-11-19

Start date

2022-01-12

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections Renal impairment

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
To investigate whether the current dosing regimen of cefuroxime, recommended by the SWAB guideline and applied at Noordwest Ziekenhuisgroep for adult patients with various degrees of renal function on general wards, results in PK-PD target attainment of 50%T>MIC after 24-48 hours of therapy. To investigate whether the current dosing regimen of cefuroxime, recommended by the SWAB guideline and applied at Noordwest Ziekenhuisgroep for adult patients with various degrees of renal function on general wards, results in PK-PD target attainment of 100%T>MIC during the first 24 hours of therapy. To compare cefuroxime exposure at 24 hours and 24-48 hours after start of treatment between two different renal function groups in terms of AUC and Cmin. (Group A: eGFR >=30ml/min/1.73m2 treated with standard doses of cefuroxime, Group B: eGFR 29-10 ml/min/1.73m2 treated with reduced doses of cefuroxime). If a large proportion, defined as a percentage of 25% or a minimum of 10 patients, does not attain the primary objective (50%T>MIC), we will explore whether or not attaining this target is associated with patients* clinical outcome, in terms of: length of hospital stay (LOS), since start of cefuroxime treatment, admission to and duration of ICU stay after start of cefuroxime treatment, 30 days mortality after start of cefuroxime treatment, antibiotic switch to carbapenems (meropenem, imipenem or ertapenem) within 30 days after start of treatment with cefuroxime and days of fever after start of treatment with cefuroxime	—

Measure

Time frame

To investigate whether the current dosing regimen of cefuroxime, recommended by the SWAB guideline and applied at Noordwest Ziekenhuisgroep for adult patients with various degrees of renal function on general wards, results in PK-PD target attainment of 50%T>MIC after 24-48 hours of therapy. To investigate whether the current dosing regimen of cefuroxime, recommended by the SWAB guideline and applied at Noordwest Ziekenhuisgroep for adult patients with various degrees of renal function on general wards, results in PK-PD target attainment of 100%T>MIC during the first 24 hours of therapy. To compare cefuroxime exposure at 24 hours and 24-48 hours after start of treatment between two different renal function groups in terms of AUC and Cmin. (Group A: eGFR >=30ml/min/1.73m2 treated with standard doses of cefuroxime, Group B: eGFR 29-10 ml/min/1.73m2 treated with reduced doses of cefuroxime). If a large proportion, defined as a percentage of 25% or a minimum of 10 patients, does not attain the primary objective (50%T>MIC), we will explore whether or not attaining this target is associated with patients* clinical outcome, in terms of: length of hospital stay (LOS), since start of cefuroxime treatment, admission to and duration of ICU stay after start of cefuroxime treatment, 30 days mortality after start of cefuroxime treatment, antibiotic switch to carbapenems (meropenem, imipenem or ertapenem) within 30 days after start of treatment with cefuroxime and days of fever after start of treatment with cefuroxime

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Countries

Netherlands

Outcome results