Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients

Critically Ill Patients Clinical Trial

Official title:

Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045366
• Other study ID #: S54510
• Status: Recruiting
• Start date: September 21, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Isabel Spriet, PharmD, PhD
• Phone: +32 16 34 30 80
• Email: isabel.spriet[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.

Description:

This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).

The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.

Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment with anidulafungin or caspofungin

• Admitted to an ICU ward

Exclusion Criteria:

• < 18 years

• DNR 2 or 3

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Hypoalbuminemia

Intervention

Other:
• Sample collection
Plasma and BAL sample collection

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)	The area under the concentration-time curve will be calculated	July 2020
Primary	Half-life (T1/2)	The half-life will be calculated	July 2020
Primary	Volume of distribution (Vd)	The volume of distribution will be calculated	July 2020
Primary	Clearance (CL)	The clearance will be calculated	July 2020
Primary	Maximum plasma concentration	The median maximum plasma concentration will be reported	July 2020
Primary	Minimum plasma concentration	The median minimum plasma concentration will be reported	July 2020
Primary	Average plasma concentration	The average plasma concentration will be calculated	July 2020
Secondary	Influence of serum creatinin (mg/dL) on echinocandin-exposure		July 2020
Secondary	Influence of glomerular filtration rate (ml/min) on echinocandin-exposure		July 2020
Secondary	Influence of on bilirubin on echinocandin-exposure		July 2020
Secondary	Influence of gamma-GT on echinocandin-exposure		July 2020
Secondary	Influence of alkaline phosphatase on echinocandin-exposure		July 2020
Secondary	Influence of AST on echinocandin-exposure		July 2020
Secondary	Influence of ALT on echinocandin-exposure		July 2020
Secondary	Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure		July 2020
Secondary	Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure		July 2020
Secondary	Influence of total protein on echinocandin-exposure		July 2020
Secondary	Influence of serum albumin on echinocandin-exposure		July 2020
Secondary	Influence of Ang-1 on echinocandin-exposure		July 2020
Secondary	Influence of Ang-2 on echinocandin-exposure		July 2020
Secondary	Influence of VEGF on echinocandin-exposure		July 2020
Secondary	Influence of inflammation (CRP) on echinocandin-exposure		July 2020
Secondary	Influence of fluid balance (mL) on echinocandin-exposure		July 2020
Secondary	Influence of prothrombin time on echinocandin-exposure		July 2020