Optimal Dosage of Caspofungin in Critically Ill Patients | NCT01994096

Studies
Optimal Dosage of Caspofungin in Critically Ill Patients

NCT01994096

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Oct 30, 2015Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Critically Ill
Suspected Invasive Candidiasis

Interventions

Caspofungin

Countries

Netherlands

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 19, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 25, 2013Estimated

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

Oct 29, 2015

Last Update Posted Date

Oct 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

JWC Alffenaar, PharmD, PhD, University Medical Center GroningenPrincipal Investigator

Lead Sponsor

University Medical Center GroningenOTHER

Collaborators

Not provided

Description Module

Brief Summary

Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score.

As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caspofungin	Experimental	1 arm, dose adjustment of caspofungin when exposure is inadequate	Drug: Caspofungin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caspofungin	Drug		Caspofungin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.		7 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters of caspofungin in critically ill patients.		3 days
Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.		3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment with caspofungin.
Admission to an ICU.
Age ≥ 18 years.
Suspected invasive candidiasis, established by the physician.

Exclusion Criteria:

Blood sampling by central venous catheter or peripheral cannula not possible.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan-Willem Alffenaar, PharmD, PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Groningen		Groningen	Provincie Groningen	9700 RB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27855112	Derived	van der Elst KC, Veringa A, Zijlstra JG, Beishuizen A, Klont R, Brummelhuis-Visser P, Uges DR, Touw DJ, Kosterink JG, van der Werf TS, Alffenaar JC. Low Caspofungin Exposure in Patients in Intensive Care Units. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01582-16. doi: 10.1128/AAC.01582-16. Print 2017 Feb.

Type	Date	Date Unknown
Release	Dec 3, 2018
Reset	Mar 21, 2019

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins