A B-D-Glucan Driven Antifungal Stewardship Approach for Invasive Candidiasis
Invasive Candidiases, Abdominal Infection
About this trial
This is an interventional other trial for Invasive Candidiases focused on measuring beta-d-glucan, abdominal candidiasis
Eligibility Criteria
Inclusion Criteria:
- a. adult (≥ 18 year) patients; b. signed informed consent before surgical procedure; c. severe sepsis or septic shock; d. 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.
Exclusion Criteria:
- a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (<0.5 × 109 neutrophils/L [<500 neutrophils/mm3] for >10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count < 200/mmc. f. patients with poor prognosis or unable to sign informed consent.
Sites / Locations
- Azienda Ospealiero Universitaria di Bologna Policlinico S.Orsola-MalpighiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
De-escalation
Standard of care
In this group, investigators will manage the antifungal therapy according to the BG levels as follows: antifungal therapy will be stopped immediately after the BG response in case of serum BG <80 pg/ml in presence of clinical stability (CS); antifungal therapy will be continued until further BG determination, both for BG levels between 80-200 pg/ml and for BG <80 pg/ml in patients without CS. In these cases, if the following BG value is <80 pg/ml antifungal therapy will be stopped independently from the CS achievement. antifungal therapy will be continued until day 10 for BG levels >200 pg/ml
In this group antifungal treatment will be continued until clinician's decision. Investigators will be blinded to the BG levels of patients enrolled in this arm, The BG results will be faxed directly to the coordinating center.