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

April 8, 2021 updated by: Fadoi Foundation, Italy

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Acquaviva Delle Fonti, Italy
        • Osp. Generale Regionale F. Miulli
      • Baggiovara, Italy
        • Nuovo Ospedale Civile S. Agostino-Estense
      • Bussolengo, Italy
        • Ospedale di Bussolengo
      • Castelnovo Ne' Monti, Italy
        • Ospedale "S. Anna"
      • Ceva, Italy
        • ASL CN1 Ospedale di Ceva
      • Chieri, Italy
        • Ospedale Maggiore
      • Como, Italy
        • Ospedale "S. Anna"
      • Domodossola, Italy
        • Ospedale "S. Biagio"
      • Genova, Italy
        • Ente Ospedaliero Galliera
      • Legnago, Italy
        • Ospedale "Mater Salutis"
      • Mirandola, Italy
        • Ospedale "S.M. Bianca"
      • Mondovì, Italy
        • Ospedale di Mondovì,
      • Napoli, Italy
        • Ospedale "Antonio Cardarelli
      • Pozzuoli, Italy
        • Presidio Ospedaliero S. Maria Delle Grazie
      • San Bonifacio, Italy
        • Ospedale "G. Fracastoro"
      • Sassuolo, Italy
        • Nuovo Ospedale Civile di Sassuolo
      • Savigliano, Italy
        • Ospedale Maggiore SS. Annunziata
      • Sestri Levante, Italy
        • Ospedale Civile di Sestri Levante
      • Verona, Italy
        • Policlinico Borgo Roma
      • Villafranca Di Verona, Italy
        • Ospedale "Magalini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura
Time Frame: 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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.
Time Frame: 14 days
Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions
14 days
To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
Time Frame: 14 days
Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fadoi Foundation, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2018

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

April 5, 2019

First Posted (ACTUAL)

April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FADOI.02.2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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