Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis|
- 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 ]
- 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
|Study Start Date:||June 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047267
|University Medical Center Groningen|
|Groningen, Netherlands, 9713GZ|
|Study Chair:||JWC Alffenaar, PharmD, PhD||University Medical Centre Groningen|
|Principal Investigator:||MJP van Wanrooy, PharmD||University Medical Centre Groningen|