Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

April 5, 2012 updated by: JWC Alffenaar, University Medical Center Groningen

Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

Study Overview

Status

Completed

Conditions

Detailed Description

One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.

For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with invasive candidiasis admitted to an intensive care unit.

Description

Inclusion Criteria:

  • treatment with anidulafungin
  • at least 18 years of age
  • invasive candidiasis
  • admitted to an intensive care unit

Exclusion Criteria:

  • allergic to anidulafungin or its excipients
  • contra-indication stated in SPC
  • neutropenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time (in days) to culture conversion
Time Frame: max 28 days
max 28 days
Response to treatment at day 28
Time Frame: 28 days
28 days
Mortality at day 28 due to fungal infection and overall mortality at 28 days
Time Frame: 28 days
28 days
AUC/MIC ratio, time above MIC
Time Frame: max 28 days
max 28 days
Composing a pharmacokinetic model of anidulafungin in critically ill patients
Time Frame: max 28 days
max 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Study Chair: JWC Alffenaar, PharmD, PhD, University Medical Center Groningen
  • Principal Investigator: MJP van Wanrooy, PharmD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANIDULA-133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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