Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04470973
Status:
UNKNOWN
Last Update Posted:
2022-09-10
First Post:
2020-07-09
Brief Title:
Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHARAOH
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None