Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
1 other identifier
observational
60
1 country
1
Brief Summary
This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2012
Longer than P75 for all trials
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
Study Start
First participant enrolled
September 21, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 3, 2024
July 1, 2024
12.8 years
June 14, 2019
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Area under the curve (AUC)
The area under the concentration-time curve will be calculated
July 2020
Half-life (T1/2)
The half-life will be calculated
July 2020
Volume of distribution (Vd)
The volume of distribution will be calculated
July 2020
Clearance (CL)
The clearance will be calculated
July 2020
Maximum plasma concentration
The median maximum plasma concentration will be reported
July 2020
Minimum plasma concentration
The median minimum plasma concentration will be reported
July 2020
Average plasma concentration
The average plasma concentration will be calculated
July 2020
Secondary Outcomes (17)
Influence of serum creatinin (mg/dL) on echinocandin-exposure
July 2020
Influence of glomerular filtration rate (ml/min) on echinocandin-exposure
July 2020
Influence of on bilirubin on echinocandin-exposure
July 2020
Influence of gamma-GT on echinocandin-exposure
July 2020
Influence of alkaline phosphatase on echinocandin-exposure
July 2020
- +12 more secondary outcomes
Interventions
Plasma and BAL sample collection
Eligibility Criteria
Critically ill patients.
You may qualify if:
- Treatment with anidulafungin or caspofungin
- Admitted to an ICU ward
You may not qualify if:
- \< 18 years
- DNR 2 or 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- KU Leuvencollaborator
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Biospecimen
Blood and BAL (bronchoalveolar lavage)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabel Spriet, PharmD, PhD
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2019
First Posted
August 5, 2019
Study Start
September 21, 2012
Primary Completion
July 1, 2025
Study Completion
December 31, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07