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Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

NCT04470973 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-09-10

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Septic Shock
  • Infection, Bacterial
  • Critically Ill

Interventions

DRUG

Cefuroxime

Patients receive cefuroxime as part of standard care.

DRUG

Amikacin

Patients receive amikacin as part of standard care.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Roger Brüggemann, Phd · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470973 on ClinicalTrials.gov