Expired Study
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Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00106288


Primary Contact:

Study Chair
Use Central Contact
Astellas Pharma Europe B.V.


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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