A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects (INTENSE)

This is an interventional prevention trial for Mycoses focused on measuring mycoses, Micafungin, intra-abdominal surgery, invasive fungal infection, intra-abdominal infection Read More

Inclusion Criteria:

• Intra-abdominal infection requiring surgery and Intensive Care Unit stay
• If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
• If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
• Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study

Exclusion Criteria:

• Acute pancreatitis
• Neutropenia (ANC <1,000/mm3) at the time of randomization
• Infected intra-peritoneal dialysis
• Patients undergoing solid organ transplantation
• Documented invasive candidiasis at the time of randomization
• Expected survival < 48 hours
• Any systemically active anti-fungal within 14 days prior to administration of the study drug
• Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients
• Currently receiving and/or has taken an investigational drug within 28 days prior to randomization
• Pregnant woman or breast-feeding mother
• 'Do Not Resuscitate' order