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Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

Information source: VU University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Candidiasis; Candidemia

Phase: N/A

Status: Recruiting

Sponsored by: VU University Medical Center

Official(s) and/or principal investigator(s):
Vera M Middel-Baars, PharmD, Principal Investigator, Affiliation: VU University Medical Center
Eleonora L Swart, PhD, Principal Investigator, Affiliation: VU University Medical Center
Roger Brüggemann, PharmD, Principal Investigator, Affiliation: Radboud University Nijmegen Medical Center

Overall contact:
Vera M Middel-Baars, PharmD, Phone: +31 20 4445282, Email: v.middel-baars@vumc.nl

Summary

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

Clinical Details

Official title: Anidulafungin Population Kinetics in the Intensive Care Population

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Pharmacokinetic population model for anidulafungin for the ICU population

Secondary outcome:

Time until clinical and microbiological response is reached

To determine the covariates that influence the kinetics of anidulafungin.

To determine the optimal dosage(scheme) for intensive care patients.

To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.

Registration of side effects and adverse events

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Vera M Middel-Baars, PharmD, Phone: +31 20 4445282, Email: v.middel-baars@vumc.nl

Radboud University Nijmegen Medical Center, Nijmegen, Gelderland 6525 GA, Netherlands; Recruiting
Roger Brüggeman, PharmD, Phone: +31 243616405, Email: r.bruggemann@akf.umcn.nl
Roger Brüggemann, PharmD, Principal Investigator

VU University Medical Center, Amsterdam, Noord Holland 1081 HV, Netherlands; Recruiting
Vera M Middel-Baars, PharmD, Phone: +31 20 4445282, Email: v.middel-baars@vumc.nl
Eleonora L Swart, PhD, Phone: +31 20 4443524, Email: el.swart@vumc.nl
Vera M Middel-Baars, PharmD, Principal Investigator

Additional Information

Starting date: September 2011
Last updated: September 19, 2011

Page last updated: August 20, 2015

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