Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin
- Conditions
- Invasive Candidiasis
- Interventions
- Diagnostic Test: 1,3-β-D-glucan quantification
- Registration Number
- NCT03906916
- Lead Sponsor
- Fadoi Foundation, Italy
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with suspicion of invasive candidiasis 1,3-β-D-glucan quantification 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. Patients with suspicion of invasive candidiasis Micafungin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (19)
Ente Ospedaliero Galliera
🇮🇹Genova, Italy
Ospedale "Antonio Cardarelli
🇮🇹Napoli, Italy
Ospedale "S. Anna"
🇮🇹Como, Italy
Ospedale Maggiore
🇮🇹Chieri, Italy
Presidio Ospedaliero S. Maria Delle Grazie
🇮🇹Pozzuoli, Italy
Nuovo Ospedale Civile di Sassuolo
🇮🇹Sassuolo, Italy
Policlinico Borgo Roma
🇮🇹Verona, Italy
Ospedale "S. Biagio"
🇮🇹Domodossola, Italy
Ospedale "Mater Salutis"
🇮🇹Legnago, Italy
ASL CN1 Ospedale di Ceva
🇮🇹Ceva, Italy
Ospedale Maggiore SS. Annunziata
🇮🇹Savigliano, Italy
Ospedale "Magalini
🇮🇹Villafranca Di Verona, Italy
Ospedale Civile di Sestri Levante
🇮🇹Sestri Levante, Italy
Nuovo Ospedale Civile S. Agostino-Estense
🇮🇹Baggiovara, Italy
Osp. Generale Regionale F. Miulli
🇮🇹Acquaviva Delle Fonti, Italy
Ospedale di Bussolengo
🇮🇹Bussolengo, Italy
Ospedale "S.M. Bianca"
🇮🇹Mirandola, Italy
Ospedale di Mondovì,
🇮🇹Mondovì, Italy
Ospedale "G. Fracastoro"
🇮🇹San Bonifacio, Italy