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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01047267
Other study ID # ANIDULA-133
Secondary ID
Status Completed
Phase N/A
First received January 11, 2010
Last updated April 5, 2012
Start date June 2010
Est. completion date December 2011

Study information

Verified date April 2012
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels. 3 days No
Secondary Time (in days) to culture conversion max 28 days No
Secondary Response to treatment at day 28 28 days No
Secondary Mortality at day 28 due to fungal infection and overall mortality at 28 days 28 days Yes
Secondary AUC/MIC ratio, time above MIC max 28 days No
Secondary Composing a pharmacokinetic model of anidulafungin in critically ill patients max 28 days No
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