Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

• Conditions: Candidemia; Invasive Candidiasis

• Registration Number: NCT01438216
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-19
• Last Update Submitted: 2011-09-19
• Study First Posted: 2011-09-22
• Last Update Posted: 2011-09-22
• Primary Completion: 2012-02
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic population model for anidulafungin for the ICU population	1 year, after inclusion of 20 patients	The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

VU University Medical Center; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands