search
Back to results

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

Primary Purpose

Invasive Candidiasis

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
1,3-β-D-glucan quantification
Micafungin
Sponsored by
Fadoi Foundation, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Invasive Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osp. Generale Regionale F. Miulli
  • Nuovo Ospedale Civile S. Agostino-Estense
  • Ospedale di Bussolengo
  • Ospedale "S. Anna"
  • ASL CN1 Ospedale di Ceva
  • Ospedale Maggiore
  • Ospedale "S. Anna"
  • Ospedale "S. Biagio"
  • Ente Ospedaliero Galliera
  • Ospedale "Mater Salutis"
  • Ospedale "S.M. Bianca"
  • Ospedale di Mondovì,
  • Ospedale "Antonio Cardarelli
  • Presidio Ospedaliero S. Maria Delle Grazie
  • Ospedale "G. Fracastoro"
  • Nuovo Ospedale Civile di Sassuolo
  • Ospedale Maggiore SS. Annunziata
  • Ospedale Civile di Sestri Levante
  • Policlinico Borgo Roma
  • Ospedale "Magalini

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspicion of invasive candidiasis

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2018
Last Updated
April 8, 2021
Sponsor
Fadoi Foundation, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT03906916
Brief Title
Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin
Acronym
EPICA1
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was interrupted prematurely because of the low rate of recruitment.
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fadoi Foundation, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with suspicion of invasive candidiasis
Arm Type
Experimental
Arm Description
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
Diagnostic Test
Intervention Name(s)
1,3-β-D-glucan quantification
Other Intervention Name(s)
FUNGITELL
Intervention Description
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
Drug
Intervention Name(s)
Micafungin
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.
Description
Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions
Time Frame
14 days
Title
To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
Description
Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Osp. Generale Regionale F. Miulli
City
Acquaviva Delle Fonti
Country
Italy
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense
City
Baggiovara
Country
Italy
Facility Name
Ospedale di Bussolengo
City
Bussolengo
Country
Italy
Facility Name
Ospedale "S. Anna"
City
Castelnovo Ne' Monti
Country
Italy
Facility Name
ASL CN1 Ospedale di Ceva
City
Ceva
Country
Italy
Facility Name
Ospedale Maggiore
City
Chieri
Country
Italy
Facility Name
Ospedale "S. Anna"
City
Como
Country
Italy
Facility Name
Ospedale "S. Biagio"
City
Domodossola
Country
Italy
Facility Name
Ente Ospedaliero Galliera
City
Genova
Country
Italy
Facility Name
Ospedale "Mater Salutis"
City
Legnago
Country
Italy
Facility Name
Ospedale "S.M. Bianca"
City
Mirandola
Country
Italy
Facility Name
Ospedale di Mondovì,
City
Mondovì
Country
Italy
Facility Name
Ospedale "Antonio Cardarelli
City
Napoli
Country
Italy
Facility Name
Presidio Ospedaliero S. Maria Delle Grazie
City
Pozzuoli
Country
Italy
Facility Name
Ospedale "G. Fracastoro"
City
San Bonifacio
Country
Italy
Facility Name
Nuovo Ospedale Civile di Sassuolo
City
Sassuolo
Country
Italy
Facility Name
Ospedale Maggiore SS. Annunziata
City
Savigliano
Country
Italy
Facility Name
Ospedale Civile di Sestri Levante
City
Sestri Levante
Country
Italy
Facility Name
Policlinico Borgo Roma
City
Verona
Country
Italy
Facility Name
Ospedale "Magalini
City
Villafranca Di Verona
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs