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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.
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.
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with invasive candidiasis admitted to an intensive care unit.
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| Name | Affiliation | Role |
|---|---|---|
| JWC Alffenaar, PharmD, PhD | University Medical Center Groningen | Study Chair |
| MJP van Wanrooy, PharmD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25487797 | Derived | 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. | |
| 24165173 | Derived | 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. |
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D016638 | Critical Illness |
| D002177 | Candidiasis |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
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plasma
| 28 days |
| AUC/MIC ratio, time above MIC | max 28 days |
| Composing a pharmacokinetic model of anidulafungin in critically ill patients | max 28 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |