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

Invasive Candidiasis Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03906916
• Other study ID #: FADOI.02.2017
• Status: Terminated
• Phase: Phase 4
• Start date: July 18, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2021
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Diagnostic Test:
• 1,3-ß-D-glucan quantification
Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-ß-D-glucan test and by means of blood culture to confirm the diagnosis

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-ß-D-glucan test.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the equivalence between two diagnostic test for Candida infections: 1,3-ß-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-ß-D-glucan test (1,3-ß-D-glucan concentrations > 200 pg/ml) for the same patient's blood sample.	14 days
Secondary	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	14 days
Secondary	To describe the trend of 1,3-ß-D-glucan in patients during micafungin treatment	Will be measured the 1,3-ß-D-glucan concentrations in in patients during micafungin treatment	14 days