Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Critically Ill Clinical Trial

Official title:

Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047267
• Other study ID #: ANIDULA-133
• 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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Critical Illness
• Critically Ill
• Invasive Candidiasis

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