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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001911-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.
Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done.
Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen.
20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VUmc IC | Due to multicentre, 2 groups of patient in 1 cohort | ||
| UMCN IC | Due to multicentre, 2 groups of patient in 1 cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic population model for anidulafungin for the ICU population | The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model. | 1 year, after inclusion of 20 patients |
| Measure | Description | Time Frame |
|---|---|---|
| Time until clinical and microbiological response is reached | Registration of time till response | 1 year, after inclusion of 20 patients |
| To determine the covariates that influence the kinetics of anidulafungin. |
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Inclusion Criteria:
Patient is admitted to the intensive care unit
Patient has a central (venous) infusion line
Patient is at least 18 years old
Patient receives treatment with anidulafungin
Exclusion Criteria:
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Intensive Care patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera M Middel-Baars, PharmD | Contact | +31 20 4445282 | v.middel-baars@vumc.nl | |
| Eleonora L. Swart, PhD | Contact | +31 20 4443524 | el.swart@vumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Vera M Middel-Baars, PharmD | Amsterdam UMC, location VUmc | Principal Investigator |
| Eleonora L Swart, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Center | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27872072 | Derived | Bruggemann RJ, Middel-Baars V, de Lange DW, Colbers A, Girbes AR, Pickkers P, Swart EL. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01894-16. doi: 10.1128/AAC.01894-16. Print 2017 Feb. |
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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whole blood
With the help from modeling program NONMEM
| 1 year, after inclusion of 20 patients |
| To determine the optimal dosage(scheme) for intensive care patients. | Calculation of optimal dosage can be done by NONMEM. | 1 year, after inclusion of 20 patients |
| To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC. | If the actual MIC is known, this can can be determined. | 1 year, after inclusion of 20 patients |
| Registration of side effects and adverse events | To register safety od anidulafungin use on ICU | 1 year, after inclusion of 20 patients |
| Roger Brüggemann, PharmD |
| Radboud University Nijmegen Medical Center |
| Principal Investigator |
| VU University Medical Center | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
|
| D000072742 |
| Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |