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

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

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.

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)

Study Design

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

Conditions

Mycoses

Intervention

micafungin, placebo

Location

Innsbruck
Austria
6020

Status

Not yet recruiting

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

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.

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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