Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

September 17, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Liposomal Amphotericin B
IV
Other Names:
  • AmBisome
EXPERIMENTAL: 1
Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 6 and 12 weeks post treatment
6 and 12 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
Throughout study and post treatment followup period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

March 22, 2005

First Submitted That Met QC Criteria

March 22, 2005

First Posted (ESTIMATE)

March 23, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-463-21-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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