Mycoses Clinical Trial
Official title:
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)
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