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

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

Subjects will be assessed at the following visits:

• Baseline (after surgery, prior to randomization)
• End of Treatment (EOT) visit (EOT is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death)
• End of Study visit (28 days after the EOT visit)
• Long-term Follow up visit (90 days after the EOT visit)

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