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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01438216
Other study ID # ANIPKIC001
Secondary ID 2011-001911-30
Status Recruiting
Phase N/A
First received September 14, 2011
Last updated September 19, 2011
Start date September 2011
Est. completion date March 2012

Study information

Verified date September 2011
Source VU University Medical Center
Contact Vera M Middel-Baars, PharmD
Phone +31 20 4445282
Email v.middel-baars@vumc.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Netherlands VU University Medical Center Amsterdam Noord Holland
Netherlands Radboud University Nijmegen Medical Center Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
VU University Medical Center Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Time until clinical and microbiological response is reached Registration of time till response 1 year, after inclusion of 20 patients No
Secondary To determine the covariates that influence the kinetics of anidulafungin. With the help from modeling program NONMEM 1 year, after inclusion of 20 patients No
Secondary 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 No
Secondary 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 No
Secondary Registration of side effects and adverse events To register safety od anidulafungin use on ICU 1 year, after inclusion of 20 patients Yes
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