Candidiasis
Conditions
Keywords
Candidaemia, Micafungin
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.
Interventions
DRUGMicafungin
IV
DRUGLiposomal Amphotericin B
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Incidence of acute infusion related reactions as pre-defined | During the 2 to 8 week treatment 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 |
| Overall incidence of Adverse Events (AE) | Throughout study and post treatment followup period |
| Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline | During the 2 to 8 week treatment period |
Countries
Canada, United States
Outcome results
None listed