Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

NCT04470973 | Unknown FDA Drug

• 1 other identifier: PHARAOH
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; Infection, Bacterial; Critically Ill

Keywords

Sepsis; Septic Shock; Infection; Critically Ill

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime

  1 year

• 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

Other Outcomes (1)

• To investigate to what extend renal replacement therapy affects the pharmacokinetics of amikacin and cefuroxime

  1 year

Study Arms (1)

Cefuroxime/Amikacin

20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.

Drug: Cefuroxime; Drug: Amikacin

Interventions

Cefuroxime DRUG

Patients receive cefuroxime as part of standard care.

Cefuroxime/Amikacin

Amikacin DRUG

Patients receive amikacin as part of standard care.

Cefuroxime/Amikacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to the ICU or ED.

You may qualify if:

• The patient is admitted to the ICU or ED;
• Is managed with a central venous catheter or arterial line;
• Is treated with amikacin and/or cefuroxime as standard care.

You may not qualify if:

• \. Has previously participated in this study.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc intensive care

Nijmegen, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and 24 hours urine will be collection following an intravenous gift of either cefuroxime or amikacin.

MeSH Terms

Conditions

Sepsis; Shock, Septic; Bacterial Infections; Critical Illness; Infections

Interventions

Cefuroxime; Amikacin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacterial Infections and Mycoses; Disease Attributes

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Roger Brüggemann, Phd

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Machiels, MD, MSc

CONTACT

+31243614369; julian.machiels@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: July 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

NL (1)