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

NCT ID: NCT03906916

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2019-02-01

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).

Conditions

Invasive Candidiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with suspicion of invasive candidiasis

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.

Group Type: EXPERIMENTAL

1,3-β-D-glucan quantification

Intervention Type: DIAGNOSTIC_TEST

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

Micafungin

Intervention Type: DRUG

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.

Interventions

1,3-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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DRUG

Other Intervention Names

FUNGITELL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fadoi Foundation, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Osp. Generale Regionale F. Miulli

Acquaviva delle Fonti, , Italy

Nuovo Ospedale Civile S. Agostino-Estense

Baggiovara, , Italy

Ospedale di Bussolengo

Bussolengo, , Italy

Ospedale "S. Anna"

Castelnovo ne' Monti, , Italy

ASL CN1 Ospedale di Ceva

Ceva, , Italy

Ospedale Maggiore

Chieri, , Italy

Ospedale "S. Anna"

Como, , Italy

Ospedale "S. Biagio"

Domodossola, , Italy

Ente Ospedaliero Galliera

Genova, , Italy

Ospedale "Mater Salutis"

Legnago, , Italy

Ospedale "S.M. Bianca"

Mirandola, , Italy

Ospedale di Mondovì,

Mondovì, , Italy

Ospedale "Antonio Cardarelli

Napoli, , Italy

Presidio Ospedaliero S. Maria Delle Grazie

Pozzuoli, , Italy

Ospedale "G. Fracastoro"

San Bonifacio, , Italy

Nuovo Ospedale Civile di Sassuolo

Sassuolo, , Italy

Ospedale Maggiore SS. Annunziata

Savigliano, , Italy

Ospedale Civile di Sestri Levante

Sestri Levante, , Italy

Policlinico Borgo Roma

Verona, , Italy

Ospedale "Magalini

Villafranca di Verona, , Italy

Countries

Italy

Other Identifiers

FADOI.02.2017

Identifier Type: -

Identifier Source: org_study_id