Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-27 @ 2:09 AM
Study NCT ID:
NCT01047267
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: