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
  Purpose

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 Intervention Phase
Candidiasis
Drug: Micafungin
Drug: Liposomal Amphotericin B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

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 ] [ 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 ]

Enrollment: 637
Study Start Date: January 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2 Drug: Liposomal Amphotericin B
IV
Other Name: AmBisome

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106288

  Show 37 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00106288     History of Changes
Other Study ID Numbers: FG-463-21-08
Study First Received: March 22, 2005
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Thailand: Ministry of Public Health
South Africa: Medicines Control Council
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Bulgaria: Bulgarian Drug Agency
Switzerland: Swissmedic
Ireland: Irish Medicines Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Portugal: National Pharmacy and Medicines Institute
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Slovenia: Ministry of Health
Croatia: Ministry of Health and Social Care
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Austria: Federal Ministry for Health and Women

Keywords provided by Astellas Pharma Inc:
Candidaemia
Micafungin

Additional relevant MeSH terms:
Candidemia
Candidiasis
Candidiasis, Invasive
Fungemia
Infection
Inflammation
Mycoses
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Amphotericin B
Liposomal amphotericin B
Micafungin
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014