Clinical trial NCT01047267: Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
Official title: Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Candidiasis
Critically Ill
Keywords: candidiasis
invasive fungal disease
critically ill
anidulafungin
pharmacokinetics
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with invasive candidiasis admitted to an intensive care unit.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: Time (in days) to culture conversion
timeFrame: max 28 days
measure: Response to treatment at day 28
timeFrame: 28 days
measure: Mortality at day 28 due to fungal infection and overall mortality at 28 days
timeFrame: 28 days
measure: AUC/MIC ratio, time above MIC
timeFrame: max 28 days
measure: Composing a pharmacokinetic model of anidulafungin in critically ill patients
timeFrame: max 28 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: JWC Alffenaar, PharmD, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: MJP van Wanrooy, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.
citation: van Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.