Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

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

Detailed Description
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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.

Official Title
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Anidulafungin Population Kinetics in the Intensive Care Population

Conditions
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Invasive Candidiasis, Candidemia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VUmc IC<br>Due to multicentre, 2 groups of patient in 1 cohort | |
| UMCN IC<br>Due to multicentre, 2 groups of patient in 1 cohort | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year, after inclusion of 20 patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until clinical and microbiological response is reached | Registration of time till response | 1 year, after inclusion of 20 patients | 
| To determine the covariates that influence the kinetics of anidulafungin. | With the help from modeling program NONMEM | 1 year, after inclusion of 20 patients | 
| To determine the optimal dosage(scheme) for intensive care patients. | Calculation of optimal dosage can be done by NONMEM. | 1 year, after inclusion of 20 patients | 
| To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC. | If the actual MIC is known, this can can be determined. | 1 year, after inclusion of 20 patients | 
| Registration of side effects and adverse events | To register safety od anidulafungin use on ICU | 1 year, after inclusion of 20 patients | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Intensive Care, Candidemia, Invasive candidiasis, Anidulafungin