Clinical trial NCT03906916: Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Invasive Candidiasis
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura
timeFrame: 14 days
Secondary outcomes:
measure: To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.
timeFrame: 14 days
measure: To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
timeFrame: 14 days
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Osp. Generale Regionale F. Miulli
city: Baggiovara
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense
city: Bussolengo
country: Italy
facility: Ospedale di Bussolengo
city: Castelnovo Ne' Monti
country: Italy
facility: Ospedale "S. Anna"
city: Ceva
country: Italy
facility: ASL CN1 Ospedale di Ceva
city: Chieri
country: Italy
facility: Ospedale Maggiore
city: Como
country: Italy
facility: Ospedale "S. Anna"
city: Domodossola
country: Italy
facility: Ospedale "S. Biagio"
city: Genova
country: Italy
facility: Ente Ospedaliero Galliera
city: Legnago
country: Italy
facility: Ospedale "Mater Salutis"
city: Mirandola
country: Italy
facility: Ospedale "S.M. Bianca"
city: Mondovì
country: Italy
facility: Ospedale di Mondovì,
city: Napoli
country: Italy
facility: Ospedale "Antonio Cardarelli
city: Pozzuoli
country: Italy
facility: Presidio Ospedaliero S. Maria Delle Grazie
city: San Bonifacio
country: Italy
facility: Ospedale "G. Fracastoro"
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo
city: Savigliano
country: Italy
facility: Ospedale Maggiore SS. Annunziata
city: Sestri Levante
country: Italy
facility: Ospedale Civile di Sestri Levante
city: Verona
country: Italy
facility: Policlinico Borgo Roma
city: Villafranca Di Verona
country: Italy
facility: Ospedale "Magalini
Study officials:
References: