Anidulafungin Pharmacokinetics in Intensive Care Unit Patients (ANICK)

Anidulafungin Population Kinetics in the Intensive Care Population

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

Study Overview

• Status: Unknown
• Conditions: Candidemia; Invasive Candidiasis

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Vera M Middel-Baars, PharmD; Phone Number: +31 20 4445282; Email: v.middel-baars@vumc.nl
• Study Contact Backup: Name: Eleonora L. Swart, PhD; Phone Number: +31 20 4443524; Email: el.swart@vumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Recruiting
      • Radboud University Nijmegen Medical Center
      • Contact: Roger Brüggeman, PharmD; Phone Number: +31 243616405; Email: r.bruggemann@akf.umcn.nl
      • Principal Investigator: Roger Brüggemann, PharmD
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1081 HV
      • Recruiting
      • VU University Medical Center
      • Contact: Vera M Middel-Baars, PharmD; Phone Number: +31 20 4445282; Email: v.middel-baars@vumc.nl
      • Contact: Eleonora L Swart, PhD; Phone Number: +31 20 4443524; Email: el.swart@vumc.nl
      • Principal Investigator: Vera M Middel-Baars, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intensive Care patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VUmc IC; Due to multicentre, 2 groups of patient in 1 cohort
UMCN IC; Due to multicentre, 2 groups of patient in 1 cohort

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Radboud University Medical Center
• Investigators: Principal Investigator: Vera M Middel-Baars, PharmD, Amsterdam UMC, location VUmc; Principal Investigator: Eleonora L Swart, PhD, Amsterdam UMC, location VUmc; Principal Investigator: Roger Brüggemann, PharmD, Radboud University Nijmegen Medical Center

Publications and helpful links

General Publications

• Bruggemann RJ, Middel-Baars V, de Lange DW, Colbers A, Girbes AR, Pickkers P, Swart EL. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01894-16. doi: 10.1128/AAC.01894-16. Print 2017 Feb.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Estimate): September 22, 2011
• Last Update Submitted That Met QC Criteria: September 19, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Intensive Care; Candidemia; Anidulafungin; Invasive candidiasis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Mycoses; Invasive Fungal Infections; Fungemia; Candidiasis; Candidemia; Candidiasis, Invasive
• Other Study ID Numbers: ANIPKIC001; 2011-001911-30 (EudraCT Number)