Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Candidiasis

Intervention / Treatment
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* Drug: Micafungin
* Drug: Liposomal Amphotericin B


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Active Comparator: 2<br> | Drug: Liposomal Amphotericin B<br>* IV<br>* Other names: AmBisome;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candidaemia, Micafungin