Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
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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.
Condition or disease
Drug: MicafunginDrug: Liposomal Amphotericin B
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
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 Outcome Measures :
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 ]
Overall incidence of Adverse Events (AE) [ Time Frame: Throughout study and post treatment followup period ]
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.