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Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047267
First Posted: January 12, 2010
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Centre Groningen
  Purpose
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.

Condition
Invasive Candidiasis Critically Ill

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

Resource links provided by NLM:


Further study details as provided by JWC Alffenaar, University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ]

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

Biospecimen Retention:   Samples Without DNA
plasma

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with invasive candidiasis admitted to an intensive care unit.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047267


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01047267     History of Changes
Other Study ID Numbers: ANIDULA-133
First Submitted: January 11, 2010
First Posted: January 12, 2010
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by JWC Alffenaar, University Medical Centre Groningen:
candidiasis
invasive fungal disease
critically ill
anidulafungin
pharmacokinetics

Additional relevant MeSH terms:
Critical Illness
Candidiasis
Candidiasis, Invasive
Disease Attributes
Pathologic Processes
Mycoses
Invasive Fungal Infections
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents