Anidulafungin Pharmacokinetics in Intensive Care Unit Patients

Candidemia Clinical Trial

— ANICK  

Official title:

Anidulafungin Population Kinetics in the Intensive Care Population

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

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

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