Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Recruiting

• Conditions: Infection, Bacterial; Critically Ill; Sepsis; Septic Shock
• Interventions: Drug: Cefuroxime; Drug: Amikacin

• Registration Number: NCT04470973
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.

With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Study Start: 2020-07-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. The patient is admitted to the ICU or ED;
2. The patient is at least 18 years of age on the day of inclusion;
3. Is managed with a central venous catheter or arterial line;
4. Is treated with amikacin and/or cefuroxime as standard care.

Exclusion Criteria

1. Has previously participated in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cefuroxime/Amikacin	Cefuroxime	20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.
Cefuroxime/Amikacin	Amikacin	20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.

Primary Outcome Measures

Name	Time	Method
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients	1 year
To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients	1 year

Secondary Outcome Measures

Name	Time	Method
To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.	1 year
To determine the toxicity of amikacin	1 year
To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime	1 year

Trial Locations

Locations (1)

Radboudumc intensive care; 🇳🇱 Nijmegen, Netherlands