Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

Amsterdam UMC, location VUmc20 enrolled

Overview

The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.

Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done. Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen. 20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Invasive Candidiasis Candidemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is admitted to the intensive care unit * Patient has a central (venous) infusion line * Patient is at least 18 years old * Patient receives treatment with anidulafungin * that is initiated on the ICU or * that is continued on the ICU and the patient has had no more than 2 days of treatment with anidulafungin Exclusion Criteria: * Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation * Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin * A woman that is pregnant, wanting to become pregnant or nursing an infant * \< 48 hours (expected) treatment with anidulafungin on the ICU ward * Has previously participated in this trial.

Locations (2)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

RECRUITING

VU University Medical Center

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Pharmacokinetic population model for anidulafungin for the ICU population

The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.