Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

NCT ID: NCT01047267

Last Updated: 2012-04-06

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

Detailed Description

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One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.

For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.

Conditions

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Invasive Candidiasis Critically Ill

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* treatment with anidulafungin
* at least 18 years of age
* invasive candidiasis
* admitted to an intensive care unit

Exclusion Criteria

* allergic to anidulafungin or its excipients
* contra-indication stated in SPC
* neutropenia
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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JWC Alffenaar, PharmD, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

MJP van Wanrooy, PharmD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.

Reference Type DERIVED
PMID: 25487797 (View on PubMed)

van Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.

Reference Type DERIVED
PMID: 24165173 (View on PubMed)

Other Identifiers

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ANIDULA-133

Identifier Type: -

Identifier Source: org_study_id

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