Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin

Study Overview
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Brief Summary
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EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).

Official Title
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Multicenter Study to Compare Two Diagnostic Tests (1,3-β-D-glucan vs Blood Culture) in Critically Ill Patients With Suspected Invasive CAndidiasis Hospitalized in Internal Medicine Wards and Who Are Currently Timely Treated With Echinocandin (Micafungin)

Conditions
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Invasive Candidiasis

Intervention / Treatment
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* Diagnostic Test: 1,3-β-D-glucan quantification
* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years Patients giving their informed consent to participate to the study and to the use of their health data Patients with two or more SIRS criteria (hyperthermia, or hypothermia, tachycardia, tachypnea, leucocytosis or leukopenia ) Patients treated with antibiotic therapy in the last 4 weeks and with central venous catheter Patients with at least one of these conditions ( cortisone therapy/ immunosuppressive agents, total parenteral nutrition, urinary catheter, anticancer chemotherapy and major surgery in the last 3 weeks, acute pancreatitis, diabetes mellitus, liver diseases, dialysis) Exclusion Criteria: Patients with ALT, AST, bilirubin > 3 times the upper limit of normal Patients enrolled in other interventional clinical studies Patients treated with echinocandin or azolic or polyene at the time of the enrolment Pregnancy or breastfeeding Neutropenic patients HIV positive patients Central nervous system events

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with suspicion of invasive candidiasis<br>Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. | Diagnostic Test: 1,3-β-D-glucan quantification<br>* Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-β-D-glucan test and by means of blood culture to confirm the diagnosis<br>* Other names: FUNGITELL;Drug: Micafungin<br>* Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura | Will be compared the results of the two diagnostic tests for the same patient's blood sample. In particular will be evaluated if there is accordance between the Candida positivity of an emocolture and the positivity of the 1,3-β-D-glucan test (1,3-β-D-glucan concentrations > 200 pg/ml) for the same patient's blood sample. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of a pre-emptive micafungin treatment on the outcome of patients. | Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions | 14 days | 
| To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment | Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment | 14 days |