Pharmacokinetics of Micafungin in Critically Ill Patients

NCT ID: NCT01716988

Last Updated: 2017-01-12

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

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-01-31

Brief Summary

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A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. 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. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.

The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.

Detailed Description

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Conditions

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Critical Illness Invasive Candidiasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Micafungin

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Treatment with micafungin.
* Admission to an ICU.
* Age ≥ 18 years.
* Invasive candidiasis.

Exclusion Criteria

* Blood sampling 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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Jan-Willem C Alffenaar

PharmD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.

Reference Type DERIVED
PMID: 28971861 (View on PubMed)

Other Identifiers

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NL39246.042.12

Identifier Type: -

Identifier Source: org_study_id

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