Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01047267
First received: January 11, 2010
Last updated: April 5, 2012
Last verified: April 2012
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time (in days) to culture conversion [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
  • Response to treatment at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Mortality at day 28 due to fungal infection and overall mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • AUC/MIC ratio, time above MIC [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
  • Composing a pharmacokinetic model of anidulafungin in critically ill patients [ Time Frame: max 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047267

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

No publications provided

Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01047267     History of Changes
Other Study ID Numbers: ANIDULA-133
Study First Received: January 11, 2010
Last Updated: April 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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
Anidulafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014