Impact of Capillary Leak and Hypoalbuminemia on PK/PD of... | NCT04045366

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

NCT04045366

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Critically Ill Patients

Interventions

Sample collection

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2012Actual

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 14, 2019

First Submission Date that Met QC Criteria

Aug 2, 2019

First Posted Date

Aug 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Name	Class
KU Leuven	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Sample collection	Other	Plasma and BAL sample collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Influence of serum creatinin (mg/dL) on echinocandin-exposure		July 2020
Influence of glomerular filtration rate (ml/min) on echinocandin-exposure		July 2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment with anidulafungin or caspofungin
Admitted to an ICU ward

Exclusion Criteria:

< 18 years
DNR 2 or 3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabel Spriet, PharmD, PhD	Contact	+32 16 34 30 80		isabel.spriet@uzleuven.be
Ruth Van Daele, PharmD	Contact	+32 16 34 30 80		ruth.vandaele@uzleuven.be

Overall Officials

Name	Affiliation	Role
Isabel Spriet, PharmD, PhD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven	Recruiting	Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

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