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

• Status: Completed
• Trial end date: 2011-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Echinocandins; Micafungin

Criteria

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