NCT01122368

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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)

Conditions

• Mycoses

Interventions

Type	Name	Description
DRUG	micafungin	IV
DRUG	placebo	IV

Timeline

• Start date: 2010-07-13
• Primary completion: 2011-12-15
• Completion: 2011-12-15
• First posted: 2010-05-13
• Last updated: 2024-11-19

Locations

56 sites across 15 countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Romania, Spain, Switzerland, Turkey (Türkiye), United Kingdom