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

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ClinicalTrials.gov Identifier: NCT03906916
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fadoi Foundation, Italy

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
Invasive Candidiasis Diagnostic Test: 1,3-β-D-glucan quantification Drug: Micafungin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : July 18, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections


Intervention Details:
  • 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 Name: 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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906916


Contacts
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Contact: ELISA ZAGARRI, MD +39 3443898906 elisa.zagarri@fadoi.org
Contact: GUALBERTO GUSSONI, PHD 3472671635 gualberto.gussoni@gmail.com

Locations
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Italy
Osp. Generale Regionale F. Miulli Active, not recruiting
Acquaviva Delle Fonti, Italy
Nuovo Ospedale Civile S. Agostino-Estense Active, not recruiting
Baggiovara, Italy
Ospedale di Bussolengo Active, not recruiting
Bussolengo, Italy
Ospedale "S. Anna" Active, not recruiting
Castelnovo Ne' Monti, Italy
ASL CN1 Ospedale di Ceva Active, not recruiting
Ceva, Italy
Ospedale Maggiore Active, not recruiting
Chieri, Italy
Ospedale "S. Anna" Active, not recruiting
Como, Italy
Ospedale "S. Biagio" Active, not recruiting
Domodossola, Italy
Ente Ospedaliero Galliera Active, not recruiting
Genova, Italy
Ospedale "Mater Salutis" Active, not recruiting
Legnago, Italy
Ospedale "S.M. Bianca" Active, not recruiting
Mirandola, Italy
Ospedale di Mondovì, Active, not recruiting
Mondovì, Italy
Ospedale "Antonio Cardarelli Active, not recruiting
Napoli, Italy
Presidio Ospedaliero S. Maria Delle Grazie Active, not recruiting
Pozzuoli, Italy
Ospedale "G. Fracastoro" Recruiting
San Bonifacio, Italy
Contact: CLAUDIO CAPRA         
Principal Investigator: CLAUDIO CAPRA         
Nuovo Ospedale Civile di Sassuolo Active, not recruiting
Sassuolo, Italy
Ospedale Maggiore SS. Annunziata Active, not recruiting
Savigliano, Italy
Ospedale Civile di Sestri Levante Active, not recruiting
Sestri Levante, Italy
Policlinico Borgo Roma Active, not recruiting
Verona, Italy
Ospedale "Magalini Active, not recruiting
Villafranca Di Verona, Italy
Sponsors and Collaborators
Fadoi Foundation, Italy

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Responsible Party: Fadoi Foundation, Italy
ClinicalTrials.gov Identifier: NCT03906916     History of Changes
Other Study ID Numbers: FADOI.02.2017
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Invasive
Mycoses
Invasive Fungal Infections
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents