Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Astellas

Status and phase

Completed

Phase 3

Conditions

Candidiasis

Treatments

Drug: Liposomal Amphotericin B

Drug: Micafungin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00106288

FG-463-21-08

Details and patient eligibility

About

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.

Full description

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.

Enrollment

637 patients

Sex

All

Volunteers

No Healthy Volunteers

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.