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

2014-07-23 21:09:06 | BioPortfolio


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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention




micafungin, placebo




Not yet recruiting


Astellas Pharma Inc

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:06-0400

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Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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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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