Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
- Registration Number
- NCT00106288
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 637
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Micafungin - 2 Liposomal Amphotericin B -
- Primary Outcome Measures
Name Time Method 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. 6 and 12 weeks post treatment
- Secondary Outcome Measures
Name Time Method Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period 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 During the 2 to 8 week treatment period and the 12 week post treatment followup period Patient survival at the End of Therapy and at the End of Study End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period Incidence of acute infusion related reactions as pre-defined During the 2 to 8 week treatment period Overall incidence of Adverse Events (AE) Throughout study and post treatment followup period Overall incidence of emergent and recurrent fungal infections at the End of Study End of the 12 week post treatment followup peroid Independent Efficacy Review Committee's assessment of overall treatment success Prior to database lock Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline During the 2 to 8 week treatment period