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

Fadoi Foundation, Italy

Status and phase: Terminated; Phase 4

Conditions: Invasive Candidiasis

Treatments: Diagnostic Test: 1,3-β-D-glucan quantification; Drug: Micafungin

Study type: Interventional

Funder types: Other

Identifiers

NCT03906916

FADOI.02.2017

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Patients with suspicion of invasive candidiasis

Experimental group

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.

Treatment:

Diagnostic Test: 1,3-β-D-glucan quantification

Drug: Micafungin