Anidulafungin Pharmacokinetics in Intensive Care Unit Patients
NCT ID: NCT01438216
Last Updated: 2011-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2011-09-30
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VUmc IC
Due to multicentre, 2 groups of patient in 1 cohort
No interventions assigned to this group
UMCN IC
Due to multicentre, 2 groups of patient in 1 cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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V.M. Middel-Baars
PharmD, hospital pharmacist trainee
Principal Investigators
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Vera M Middel-Baars, PharmD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Eleonora L Swart, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Roger Brüggemann, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center
Locations
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Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
VU University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2011-001911-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANIPKIC001
Identifier Type: -
Identifier Source: org_study_id