Know Cancer

forgot password

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections

Phase 3
18 Years
Open (Enrolling)
Mycoses, Candidiasis, Invasive, Candidemia

Thank you

Trial Information

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections

Candida infections, representing approximately 80% of all major systemic fungal infections,
are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate
of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study
investigates the efficacy and safety of intravenous and oral Isavuconazole. Patients are
randomized to Isavuconazole and the reference regimen. Patients with a positive blood- or
deep tissue culture of candida fungi can be included.

Inclusion Criteria:

- Patients with candidemia or with an invasive Candida infection

- Presence of fever, hypothermia or other appropriate local sign of infection

- Female patients must be non-lactating and at no risk of pregnancy

Exclusion Criteria:

- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
esophageal or genital candidiasis; or candidal lower urinary tract infection or
Candida isolated solely from respiratory tract specimens

- Patients with candidemia who failed a previous antifungal therapy for the same

- Patients previously enrolled in a phase III study with isavuconazole

- Patients with a body weight <40kg

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall response

Outcome Description:

Resolution of signs and symptoms of infection plus mycological (presumed) eradication

Outcome Time Frame:

2 weeks after last study dose

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

November 2013

Related Keywords:

  • Mycoses
  • Candidiasis, Invasive
  • Candidemia
  • Phase III study
  • Isavuconazole
  • Candidemia
  • Invasive Candida infections
  • Candidemia and other invasive candida infections
  • ASP9766
  • BAL8557
  • Candidiasis
  • Mycoses
  • Candidemia
  • Candidiasis, Invasive



Johns Hopkins University Baltimore, Maryland  21205
Infectious Disease of Indiana Indianapolis, Indiana  46218
Henry Ford Hospital Detroit, Michigan  48202
New York Medical College Valhalla, New York  10595
Rush University Medical Center Chicago, Illinois  60612-3824
William Beaumont Hospital Royal Oak, Michigan  48073
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Summa Health System Akron, Ohio  44312
St. John's Hospital and Medical Center Detroit, Michigan  48236
University of Minnesota Minneapolis, Minnesota  55455
Duke University Durham, North Carolina  27710
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
University of Colorado Health Sciences Center Denver, Colorado  80262
Flint, Michigan  48532
Bend Memorial Clinic Bend, Oregon  97701
McLean, Virginia  22101
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Wilmington, Delaware  
Charleston, South Carolina  
California Pacific Medical Center San Francisco, California  94115
Washington, District of Columbia  
New York Presbyterian Hospital New York, New York  10021
University of California at San Francisco San Francisco, California  94115
Jersey Shore University Medical Center Neptune, New Jersey  07754
Coeur D'alene, Idaho  83814
VA Western New York Healthcare System Buffalo, New York  14215-1199
University of Pennsylvania Health System Philadelphia, Pennsylvania  19104
UMass Memorial Medical Center Worcester, Massachusetts  01655
University of California - Los Angeles Los Angeles, California  90095
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin  53792-5666
University of California Davis Health System Sacramento, California  95817
Stanford University Hospital Stanford, California  94303
Los Angeles Biomedical Research Institute at Harbor-UCLA Med Torrance, California  90509
University of Miami - Miller School of Medicine Miami, Florida  33136
Emory Hospital Atlanta, Georgia  30322
Indiana BMT Springfield, Illinois  62701
Brigham & Womens Hospital Boston, Massachusetts  02115
Tufts Medical Center, Inc. Boston, Massachusetts  02109
Upstate Infectious Diseases Association LLP Albany, New York  12208
Regional Infection Diseases Infusion Center Inc. Lima, Ohio  45801
Temple University Health Sciences Philadelphia, Pennsylvania  19140
Penn Memory Center Philadelphia, Pennsylvania  19104
Somero Michael Palm Desert, California  92211
University of Chicago; Division of Infectious Diseases Chicago, Illinois  60637
Loyola University Hospital Maywood, Illinois  60153
Indiana BMT Beech Grove, Indiana  46107
Kansas City VA Medical Center Kansas City, Kansas  64128
Mercury Street Medical Group Butte, Montana  59701
Remington-Davis Inc. Columbus, Ohio  43215
RSP Infectious Disease West Reading, Pennsylvania  19611
Jackson, Wyoming