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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
N/A
Open (Enrolling)
Both
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
infection

- Patients previously enrolled in a phase III study with isavuconazole

- Patients with a body weight <40kg

Type of Study:

Interventional

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:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

9766-CL-0105

NCT ID:

NCT00413218

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

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Infectious Disease of IndianaIndianapolis, Indiana  46218
Henry Ford HospitalDetroit, Michigan  48202
New York Medical CollegeValhalla, New York  10595
Rush University Medical CenterChicago, Illinois  60612-3824
William Beaumont HospitalRoyal Oak, Michigan  48073
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Summa Health SystemAkron, Ohio  44312
St. John's Hospital and Medical CenterDetroit, Michigan  48236
University of MinnesotaMinneapolis, Minnesota  55455
Duke UniversityDurham, North Carolina  27710
University of Alabama at BirminghamBirmingham, 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 CenterDenver, Colorado  80262
Flint, Michigan  48532
Bend Memorial ClinicBend, Oregon  97701
McLean, Virginia  22101
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Wilmington, Delaware  
Charleston, South Carolina  
California Pacific Medical CenterSan Francisco, California  94115
Washington, District of Columbia  
New York Presbyterian HospitalNew York, New York  10021
University of California at San FranciscoSan Francisco, California  94115
Jersey Shore University Medical CenterNeptune, New Jersey  07754
Coeur D'alene, Idaho  83814
VA Western New York Healthcare SystemBuffalo, New York  14215-1199
University of Pennsylvania Health SystemPhiladelphia, Pennsylvania  19104
UMass Memorial Medical CenterWorcester, Massachusetts  01655
University of California - Los AngelesLos Angeles, California  90095
University of Wisconsin School of Medicine and Public HealthMadison, Wisconsin  53792-5666
University of California Davis Health SystemSacramento, California  95817
Stanford University HospitalStanford, California  94303
Los Angeles Biomedical Research Institute at Harbor-UCLA MedTorrance, California  90509
University of Miami - Miller School of MedicineMiami, Florida  33136
Emory HospitalAtlanta, Georgia  30322
Indiana BMTSpringfield, Illinois  62701
Brigham & Womens HospitalBoston, Massachusetts  02115
Tufts Medical Center, Inc.Boston, Massachusetts  02109
Upstate Infectious Diseases Association LLPAlbany, New York  12208
Regional Infection Diseases Infusion Center Inc.Lima, Ohio  45801
Temple University Health SciencesPhiladelphia, Pennsylvania  19140
Penn Memory CenterPhiladelphia, Pennsylvania  19104
Somero MichaelPalm Desert, California  92211
University of Chicago; Division of Infectious DiseasesChicago, Illinois  60637
Loyola University HospitalMaywood, Illinois  60153
Indiana BMTBeech Grove, Indiana  46107
Kansas City VA Medical CenterKansas City, Kansas  64128
Mercury Street Medical GroupButte, Montana  59701
Remington-Davis Inc.Columbus, Ohio  43215
RSP Infectious DiseaseWest Reading, Pennsylvania  19611
Jackson, Wyoming