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Optimal Dosage of Caspofungin in Critically Ill Patients

NCT ID: NCT01994096

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Critically Ill Suspected Invasive Candidiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caspofungin

1 arm, dose adjustment of caspofungin when exposure is inadequate

Group Type EXPERIMENTAL

Caspofungin

Intervention Type DRUG

Interventions

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Caspofungin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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JWC Alffenaar

PharmD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan-Willem Alffenaar, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 27855112 (View on PubMed)

Other Identifiers

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NL41676.042.12

Identifier Type: -

Identifier Source: org_study_id