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Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00106288
First received: March 22, 2005
Last updated: September 17, 2014
Last verified: September 2014

March 22, 2005
September 17, 2014
January 2003
December 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00106288 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall incidence of emergent and recurrent fungal infections at the End of Study [ Time Frame: End of the 12 week post treatment followup peroid ] [ Designated as safety issue: No ]
  • Independent Efficacy Review Committee's assessment of overall treatment success [ Time Frame: Prior to database lock ] [ Designated as safety issue: No ]
  • Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline [ Time Frame: During the 2 to 8 week treatment period ] [ Designated as safety issue: No ]
  • Incidence of acute infusion related reactions as pre-defined [ Time Frame: During the 2 to 8 week treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall incidence of Adverse Events (AE) [ Time Frame: Throughout study and post treatment followup period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Candidiasis
  • Drug: Micafungin
    IV
    Other Names:
    • Mycamine
    • FK463
  • Drug: Liposomal Amphotericin B
    IV
    Other Name: AmBisome
  • Experimental: 1
    Intervention: Drug: Micafungin
  • Active Comparator: 2
    Intervention: Drug: Liposomal Amphotericin B

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
637
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00106288
FG-463-21-08
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP