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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)
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Not yet recruiting
Astellas Pharma Inc
Published on BioPortfolio: 2014-07-23T21:09:06-0400
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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Diseases caused by FUNGI.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
The study of the structure, growth, function, genetics, and reproduction of fungi, and MYCOSES.
Infections caused by bacteria and fungi, general, specified, or unspecified.
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Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...