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Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106288
Recruitment Status : Completed
First Posted : March 23, 2005
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Candidiasis Drug: Micafungin Drug: Liposomal Amphotericin B Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 : January 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
Other Names:
  • Mycamine
  • FK463

Active Comparator: 2 Drug: Liposomal Amphotericin B
Other Name: AmBisome

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. Overall incidence of emergent and recurrent fungal infections at the End of Study [ Time Frame: End of the 12 week post treatment followup peroid ]
  4. Independent Efficacy Review Committee's assessment of overall treatment success [ Time Frame: Prior to database lock ]
  5. Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline [ Time Frame: During the 2 to 8 week treatment period ]
  6. Incidence of acute infusion related reactions as pre-defined [ Time Frame: During the 2 to 8 week treatment period ]
  7. 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 ]
  8. Overall incidence of Adverse Events (AE) [ Time Frame: Throughout study and post treatment followup period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106288

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United States, Alabama
Birmingham, Alabama, United States, 35294-0006
United States, California
Orange, California, United States, 92868
United States, Colorado
Denver, Colorado, United States, 80218
United States, District of Columbia
Washington, DC, District of Columbia, United States, 20010-2970
United States, Florida
Jacksonville, Florida, United States, 32207
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Hinsdale, Illinois, United States, 60521
Maywood, Illinois, United States, 60153
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Baltimore, Maryland, United States, 21201-1595
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02211
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10029
New York, New York, United States, 10032
Rochester, New York, United States, 14642
Valhalla, New York, United States, 10595
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229-3900
United States, Utah
Provo, Utah, United States, 84604
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton, Ontario, Canada, L8V 1C3
Toronto, Ontario, Canada, M5S 2N9
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4P OW5
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc Identifier: NCT00106288    
Other Study ID Numbers: FG-463-21-08
First Posted: March 23, 2005    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents