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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
252
IV
IV
The incidence of Invasive Fungal Infection
Time frame: During treatment
Time from baseline to the first confirmation of Invasive Fungal Infection
Time frame: Baseline to End of Treatment visit
The incidence during the treatment period and the time to confirmation of the composite endpoint (defined as confirmation of Invasive Fungal Infection and/or administration of alternative anti-fungal therapy)
Time frame: At the EOT visit
The emergence or persistence of fungal colonization
Time frame: At the EOT visit
The level of organ dysfunction
Time frame: At the EOT visit
To assess the requirement for additional abdominal surgery/intervention.
Time frame: At the End of Study visit
Organ failure-free days
Time frame: From Day 1 until 28 days after end of study drug treatment
Fungal-free survival
Time frame: From Day 1 until 28 days after end of study drug treatment
Intensive Care Unit (ICU)-free days
Time frame: From Day 1 until 28 days after end of study drug treatment
All-cause mortality
Time frame: At the End of Study and Long-Term Follow Up visit
Health-related quality of life
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Unnamed facility
Innsbruck, Austria
Unnamed facility
Salzburg, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Edegem, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Viborg, Denmark
...and 46 more locations
Time frame: At the End of Study visit
Assessment of the safety of micafungin when used as a pre-emptive treatment
Time frame: At the End of Study visit