Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

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. Identifier: NCT01047267
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Center Groningen

Brief Summary:
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 or disease
Invasive Candidiasis Critically Ill

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
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Primary Outcome Measures :
  1. 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 :
  1. Time (in days) to culture conversion [ Time Frame: max 28 days ]
  2. Response to treatment at day 28 [ Time Frame: 28 days ]
  3. Mortality at day 28 due to fungal infection and overall mortality at 28 days [ Time Frame: 28 days ]
  4. AUC/MIC ratio, time above MIC [ Time Frame: max 28 days ]
  5. Composing a pharmacokinetic model of anidulafungin in critically ill patients [ Time Frame: max 28 days ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT01047267

University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Center Groningen
Study Chair: JWC Alffenaar, PharmD, PhD University Medical Center Groningen
Principal Investigator: MJP van Wanrooy, PharmD University Medical Center Groningen

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

Keywords provided by JWC Alffenaar, University Medical Center Groningen:
invasive fungal disease
critically ill

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