EPICA1: Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin

Sponsor
Fadoi Foundation, Italy (Other)
Overall Status
Terminated
CT.gov ID
NCT03906916
Collaborator
(none)
14
20
1
6.5
0.7
0.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Actual Study Start Date :
Jul 18, 2018
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Diagnostic Test: 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
Other Names:
  • FUNGITELL
  • Drug: 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osp. Generale Regionale F. Miulli Acquaviva Delle Fonti Italy
    2 Nuovo Ospedale Civile S. Agostino-Estense Baggiovara Italy
    3 Ospedale di Bussolengo Bussolengo Italy
    4 Ospedale "S. Anna" Castelnovo Ne' Monti Italy
    5 ASL CN1 Ospedale di Ceva Ceva Italy
    6 Ospedale Maggiore Chieri Italy
    7 Ospedale "S. Anna" Como Italy
    8 Ospedale "S. Biagio" Domodossola Italy
    9 Ente Ospedaliero Galliera Genova Italy
    10 Ospedale "Mater Salutis" Legnago Italy
    11 Ospedale "S.M. Bianca" Mirandola Italy
    12 Ospedale di Mondovì, Mondovì Italy
    13 Ospedale "Antonio Cardarelli Napoli Italy
    14 Presidio Ospedaliero S. Maria Delle Grazie Pozzuoli Italy
    15 Ospedale "G. Fracastoro" San Bonifacio Italy
    16 Nuovo Ospedale Civile di Sassuolo Sassuolo Italy
    17 Ospedale Maggiore SS. Annunziata Savigliano Italy
    18 Ospedale Civile di Sestri Levante Sestri Levante Italy
    19 Policlinico Borgo Roma Verona Italy
    20 Ospedale "Magalini Villafranca Di Verona Italy

    Sponsors and Collaborators

    • Fadoi Foundation, Italy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fadoi Foundation, Italy
    ClinicalTrials.gov Identifier:
    NCT03906916
    Other Study ID Numbers:
    • FADOI.02.2017
    First Posted:
    Apr 8, 2019
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2021