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Anidulafungin Pharmacokinetics in Intensive Care Unit Patients (ANICK)

This study is currently recruiting participants.
Verified September 2011 by VU University Medical Center
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
V.M. Middel-Baars, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01438216
First received: September 14, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition
Invasive Candidiasis
Candidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anidulafungin Population Kinetics in the Intensive Care Population

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Pharmacokinetic population model for anidulafungin for the ICU population [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: No ]
    The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.


Secondary Outcome Measures:
  • Time until clinical and microbiological response is reached [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: No ]
    Registration of time till response

  • To determine the covariates that influence the kinetics of anidulafungin. [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: No ]
    With the help from modeling program NONMEM

  • To determine the optimal dosage(scheme) for intensive care patients. [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: No ]
    If the actual MIC is known, this can can be determined.

  • Registration of side effects and adverse events [ Time Frame: 1 year, after inclusion of 20 patients ] [ Designated as safety issue: Yes ]
    To register safety od anidulafungin use on ICU


Biospecimen Retention:   Samples Without DNA

whole blood


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
VUmc IC
Due to multicentre, 2 groups of patient in 1 cohort
UMCN IC
Due to multicentre, 2 groups of patient in 1 cohort

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Intensive Care patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438216

Contacts
Contact: Vera M Middel-Baars, PharmD +31 20 4445282 v.middel-baars@vumc.nl
Contact: Eleonora L. Swart, PhD +31 20 4443524 el.swart@vumc.nl

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

No publications provided

Responsible Party: V.M. Middel-Baars, PharmD, hospital pharmacist trainee, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01438216     History of Changes
Other Study ID Numbers: ANIPKIC001, 2011-001911-30
Study First Received: September 14, 2011
Last Updated: September 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Pharmacokinetics
Intensive Care
Candidemia
Invasive candidiasis
Anidulafungin

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Anidulafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013