Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients. (PHARAOH)

  • End date
    Dec 15, 2023
  • participants needed
  • sponsor
    Radboud University Medical Center
Updated on 7 October 2022
antibiotic therapy
critical illness
critically ill
arterial line


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.

Condition Sepsis, Septic Shock, Infection, Bacterial, Critically Ill
Treatment amikacin, Cefuroxime
Clinical Study IdentifierNCT04470973
SponsorRadboud University Medical Center
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Has previously participated in this study
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