invasive candidiasis MedDRA version: 20.0 Level: LLT Classification code 10064954 Term: Invasive candidiasis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: TYGACIL - 50 MG POLVERE PER SOLUZIONE PER INFUSIONE 10 FLACONCINI DI VETRO 5 ML
Product Name: TYGACIL
Product Code: TYGACIL
Pharmaceutical Form: Powder for solution for infusion
INN or Pro
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. adult (= 18 year) patients; b. severe sepsis or septic shock; c. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: confirmed diagnosis of invasive candidiasis at enrollment; • Exposure to antifungal therapy in the last 30 days prior to enrollment; • Women who are pregnant and breastfeeding women; • Known or suspected hypersensitivity to any of the antifungal drugs used in the protocol (echinocandins, amphothericina B liposomal); • immunocompromised patients, one or pià of the following conditions: i) neutropenia (<0.5 × 109 neutrophils / L [<500 neutrophils / mm 3] for more than 10 days), ii) of allogeneic bone marrow transplantation, iii) congenital immunodeficiency (eg. chronic granulomatous disease, severe combined immunodeficiency), iv) HIV infection with CD4 + T lymphocyte count <200 / mmc. • Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study; • Use of experimental drugs in the last 30 days prior to study entry; • Patients unable to follow the procedures of the Protocol and to sign the informed consent at the time of the pre-surgical evaluation. • Women of childbearing potential not using effective contraception during treatment mechanical method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: demonstrate the possibility of a reduction in the duration of empiric antifungal therapy in patients with complicated surgical abdominal pathology and severe sepsis or septic shock framework through a management strategy based on seriata determination of serum levels of BDG, without a negative impact on the evolution of the clinical patient in terms of raw and duration of stay in hospital ICU mortality.;Secondary Objective: 1) demonstrate the accuracy of serial determinations of the BDG in the diagnosis of IC in patients with complicated surgical abdominal pathology and framework of severe sepsis or septic shock; 2) describe the kinetics of the BDG in relation to the treatment in a cohort of patients at high risk for ICs, differentiating on the basis of the state of colonization, infection and no event associated with Candida spp .. ;Primary end point(s): - duration of antifungal empirical therapy;Timepoint(s) of evaluation of this end point: one month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 28-day mortality, duration of hospitalization in intensive care units - Sensitivity, specificity, positive predictive value and negative predictive value for the diagnosis of invasive candidiasis of baseline and seriated BDG. The outcome of cultures (blood culture, or intraoperative samples obtained by invasive procedures) will be considered the reference standard according to the definition of invasive candidiasis above. - Kinetics of BDG in colonized patients, infected and no Candida spp related events. - Incidence of invasive candidiasis within 3 months after discontinuation of antifungal empirical therapy;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
Italy
Contacts
Public ContactU.O. Malattie Infettive - Prof.Vial
AOU di Bologna
Outcome results
None listed