Clinical trial NCT01438216: Anidulafungin Pharmacokinetics in Intensive Care Unit Patients
Official title: Anidulafungin Population Kinetics in the Intensive Care Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Candidiasis
Candidemia
Keywords: Pharmacokinetics
Intensive Care
Candidemia
Invasive candidiasis
Anidulafungin
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2011-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care patients

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.

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic population model for anidulafungin for the ICU population
timeFrame: 1 year, after inclusion of 20 patients
Secondary outcomes:
measure: Time until clinical and microbiological response is reached
timeFrame: 1 year, after inclusion of 20 patients
measure: To determine the covariates that influence the kinetics of anidulafungin.
timeFrame: 1 year, after inclusion of 20 patients
measure: To determine the optimal dosage(scheme) for intensive care patients.
timeFrame: 1 year, after inclusion of 20 patients
measure: To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.
timeFrame: 1 year, after inclusion of 20 patients
measure: Registration of side effects and adverse events
timeFrame: 1 year, after inclusion of 20 patients
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Vera M Middel-Baars, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Eleonora L Swart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Center
name: Roger Brüggemann, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.