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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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