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

NCT03906916 | Terminated Phase 4

• 1 other identifier: FADOI.02.2017
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 20

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.

  14 days

• To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment

  14 days

Study Arms (1)

Patients with suspicion of invasive candidiasis

EXPERIMENTAL

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; Drug: Micafungin

Interventions

1,3-β-D-glucan quantification 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

Also known as: FUNGITELL

Patients with suspicion of invasive candidiasis

Micafungin 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.

Patients with suspicion of invasive candidiasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Study Sites (20)

Osp. Generale Regionale F. Miulli

Acquaviva delle Fonti, Italy

Location

Nuovo Ospedale Civile S. Agostino-Estense

Baggiovara, Italy

Location

Ospedale di Bussolengo

Bussolengo, Italy

Location

Ospedale "S. Anna"

Castelnovo ne' Monti, Italy

Location

ASL CN1 Ospedale di Ceva

Ceva, Italy

Location

Ospedale Maggiore

Chieri, Italy

Location

Ospedale "S. Anna"

Como, Italy

Location

Ospedale "S. Biagio"

Domodossola, Italy

Location

Ente Ospedaliero Galliera

Genova, Italy

Location

Ospedale "Mater Salutis"

Legnago, Italy

Location

Ospedale "S.M. Bianca"

Mirandola, Italy

Location

Ospedale di Mondovì,

Mondovì, Italy

Location

Ospedale "Antonio Cardarelli

Napoli, Italy

Location

Presidio Ospedaliero S. Maria Delle Grazie

Pozzuoli, Italy

Location

Ospedale "G. Fracastoro"

San Bonifacio, Italy

Location

Nuovo Ospedale Civile di Sassuolo

Sassuolo, Italy

Location

Ospedale Maggiore SS. Annunziata

Savigliano, Italy

Location

Ospedale Civile di Sestri Levante

Sestri Levante, Italy

Location

Policlinico Borgo Roma

Verona, Italy

Location

Ospedale "Magalini

Villafranca di Verona, Italy

Location

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: April 8, 2019
• Study Start: July 18, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2019
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

IT (20)