Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Astellas Pharma Inc637 enrolled

Overview

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 invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

637

Conditions

Candidiasis

Interventions

MicafunginDRUG

Liposomal Amphotericin BDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.

Time frame: 6 and 12 weeks post treatment

Secondary Outcomes

Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period

Time frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period

Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period

Time frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period

Overall incidence of emergent and recurrent fungal infections at the End of Study

Time frame: End of the 12 week post treatment followup peroid

Independent Efficacy Review Committee's assessment of overall treatment success

Time frame: Prior to database lock

Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline

Time frame: During the 2 to 8 week treatment period

Incidence of acute infusion related reactions as pre-defined

Time frame: During the 2 to 8 week treatment period

Patient survival at the End of Therapy and at the End of Study

Time frame: End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Orange, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Hinsdale, Illinois, United States

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Maywood, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

...and 27 more locations