Clinical Trial: Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

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.

Detailed Summary:

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.


Sponsor: University Medical Center Groningen

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: January 11, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 5, 2012
Last Verified: April 2012