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 reachedTo 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
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