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
18 Years
N/A
Both
Mycoses, Candidiasis, Invasive, Candidemia
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 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 |
