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Empirical Antifungal Treatment in ICUS

NCT01773876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2015-03-24

No results posted yet for this study

Summary

Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.

Conditions

  • Invasive Candidiasis

Interventions

DRUG

Micafungin

MYCAMINE 100 mg intravenous 100 mg of powder reconstituted in a 100 ml infusion bag of sodium chloride 0.9% infusion over 24 hours for 14 days discontinuation of treatment if proven invasive candidiasis

DRUG

PLACEBO

solution of sodium chloride 0.9% 100 ml for intravenous infusion infusion over 24 hours for 14 days discontinuation of placebo if proven invasive candidiasis

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • TIMSIT JFT Jean François, PU-PH · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773876 on ClinicalTrials.gov