Anidulafungin Pharmacokinetics in Intensive Care Unit Patients (ANICK)

Amsterdam UMC, location VUmc

Status

Unknown

Conditions

Candidemia

Invasive Candidiasis

Study type

Observational

Funder types

Other

Identifiers

NCT01438216

ANIPKIC001

2011-001911-30 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.