Critically Ill Clinical Trial
Official title:
Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
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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