Table 1 Inclusion and non inclusion criteria
Main inclusion criteria | • Age ≥ 18 years |
• Hospitalization in ICU ≥ five days (120 hours) before randomization | |
• Suspected but unproven candidiasis: | |
Systemic inflammatory response syndrome (SIRS) manifested by two signs among four (body temperature < 36°C or > 38°C; heart rate > 90/minute; respiratory rate > 20/minute or PaCO2 < 32 mmHg; white blood cells > 12,000/mm3, < 4,000/mm3 or > 10% of circulating immature forms) | |
Mechanical ventilation ≥ four days | |
Presence of a central vein catheter and/or an arterial line | |
Use of broad spectrum antibacterial agents ≥ four days during the last seven days | |
• Organ failure is defined as a sepsis-related organ failure assessment (SOFA) score ≥ 3 | |
• At least one extra-digestive site of Candida sp. colonization (urine, mouth, throat, upper and lower respiratory system, skin folds and drains and postoperative aspiration, and so on); positive samples from rectal swab and/or stool culture are not taken into account although they are collected at randomization visit | |
• No evidence of bacterial infections that explain the symptoms | |
• No evidence of invasive fungal infections (positive blood culture, direct examination or positive culture from surgery site, deep biopsy with mycosis) or mould infection according to the criteria of the ‘fungal infection cooperative group of EORTC’ [De Pauw 2008 ] | |
Main non inclusion criteria | • Proven invasive infection (positive blood culture with yeast, positive culture from surgery site (only samples taken during surgery or by percutaneous puncture), deep biopsy with mycosis) including aspergillosis requiring antifungal treatment at the time of randomization |
• Patients status considered by the investigator to inevitably leading to death or to withdrawal of life support within 48 hours | |
• Antifungal treatment with an echinocandin > one day or with any other antifungal agent > 72 hours the week preceding the inclusion | |
• Allergy, hypersensitivity or known intolerance to antifungal echinocandins or to any excipient composing the study drug | |
• Neutropenia (neutrophil count < 500/mm3) | |
• Previous marrow or organ transplantation | |
• Recent chemotherapy (since less than six months) | |
• Ongoing systemic immunosuppressant agents therapy, other than corticosteroids at doses < 2 mg/kg/day of prednisolone or equivalent |