Invasive Candidiasis
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TEST1,3-β-D-glucan quantification
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
DRUGMicafungin
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.
Sponsors
Fadoi Foundation, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of a pre-emptive micafungin treatment on the outcome of patients. | 14 days | Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions |
| To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment | 14 days | Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment |
Countries
Italy
Outcome results
None listed