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COMPLETEDPhase 3NCT00106288

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed i...

Lead sponsor: Astellas Pharma Inc•27 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Astellas Pharma Inc

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients either non-neutropenic with absolute neutrophil counts \>= 500 cells/mm3 or neutropenic with absolute neutrophil counts \< 500 cells/mm3 must have:
•Candidemia or invasive candidiasis,
•Confirmation and typical clinical signs and symptoms by fungal culture and/or histology,
•Positive culture obtained no more than four days prior to the first dose of study medication.

Exclusion Criteria

•Patient is pregnant or nursing
•Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT \> 10 times the upper limit of normal (ULN); or b) Total bilirubin \> 5 times ULN.
•Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.
•Patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 18, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment637

Start dateJan 2003

Last updatedSep 18, 2014

Condition

Locations shown

Birmingham, Alabama

Orange, California

Denver, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2014Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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