Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01047267

Enrollment

Registered

2010-01-12

Start date

2010-06-30

Completion date

2011-12-31

Last updated

2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Invasive Candidiasis

Keywords

candidiasis, invasive fungal disease, critically ill, anidulafungin, pharmacokinetics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Netherlands

Outcome results