Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Sepsis Clinical Trial

— PHARAOH  

Official title:

Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470973
• Other study ID #: PHARAOH
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: September 2022
• Source: Radboud University Medical Center
• Contact: Julian Machiels, MD, MSc
• Phone: +31243614369
• Email: julian.machiels[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Critical Illness
• Critically Ill
• Infection, Bacterial
• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Drug:
• Cefuroxime
Patients receive cefuroxime as part of standard care.
• Amikacin
Patients receive amikacin as part of standard care.

Locations

Country	Name	City	State
Netherlands	Radboudumc intensive care	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To investigate to what extend renal replacement therapy affects the pharmacokinetics of amikacin and cefuroxime		1 year
Primary	To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients		1 year
Primary	To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients		1 year
Secondary	To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime		1 year
Secondary	To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.		1 year
Secondary	To determine the toxicity of amikacin		1 year