Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Completed

• Conditions: Invasive Candidiasis; Critically Ill

• Registration Number: NCT01047267
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Start: 2010-06
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Composing a pharmacokinetic model of anidulafungin in critically ill patients	max 28 days
Time (in days) to culture conversion	max 28 days
AUC/MIC ratio, time above MIC	max 28 days
Mortality at day 28 due to fungal infection and overall mortality at 28 days	28 days
Response to treatment at day 28	28 days

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands