Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 6, 2012
April 1, 2012
1.4 years
January 11, 2010
April 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
3 days
Secondary Outcomes (5)
Time (in days) to culture conversion
max 28 days
Response to treatment at day 28
28 days
Mortality at day 28 due to fungal infection and overall mortality at 28 days
28 days
AUC/MIC ratio, time above MIC
max 28 days
Composing a pharmacokinetic model of anidulafungin in critically ill patients
max 28 days
Eligibility Criteria
Adult patients with invasive candidiasis admitted to an intensive care unit.
You may qualify if:
- treatment with anidulafungin
- at least 18 years of age
- invasive candidiasis
- admitted to an intensive care unit
You may not qualify if:
- allergic to anidulafungin or its excipients
- contra-indication stated in SPC
- neutropenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Related Publications (2)
van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.
PMID: 25487797DERIVEDvan Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.
PMID: 24165173DERIVED
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
JWC Alffenaar, PharmD, PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
MJP van Wanrooy, PharmD
University Medical Center Groningen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD, PhD
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 12, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
April 6, 2012
Record last verified: 2012-04