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Trial record 9 of 15 for:
candidiasis | astellas [Lead]
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00413218
First received: December 18, 2006
Last updated: September 2, 2015
Last verified: August 2015
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Purpose
The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
| Condition | Intervention | Phase |
|---|---|---|
| Mycoses Candidiasis, Invasive Candidemia | Drug: Isavuconazole Drug: Caspofungin Drug: Voriconazole | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Yeast Infections
Drug Information available for:
Voriconazole
Caspofungin
Caspofungin acetate
Isavuconazonium sulfate
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Overall response at end of intravenous (IV) therapy [ Time Frame: Up to the maximum duration of therapy of 56 days ]Resolution of signs and symptoms of infection plus mycological (presumed) eradication as assessed by an independent Data Review Committee (DRC)
Secondary Outcome Measures:
- Overall response [ Time Frame: Day 7, end of treatment (up to day 56) 2 weeks after last day of study drug, 6 weeks after last study drug ]Resolution of signs and symptoms of infection plus mycological (presumed) eradication as assessed by an independent DRC
- Mycological response as determined by the independent DRC [ Time Frame: End of IV therapy (up to the maximum duration of therapy of 56 days), end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ]
- Clinical response as determined by the independent DRC [ Time Frame: End of IV therapy (up to the maximum duration of therapy of 56 days), end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ]
- Mycological response as determined by the investigator [ Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ]
- Clinical response as determined by the investigator [ Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ]
- Time to first confirmed negative culture [ Time Frame: Up to 2 weeks after last study drug ]
- All-cause mortality [ Time Frame: Day 14, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ]
| Enrollment: | 450 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2015 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Isavuconazole |
Drug: Isavuconazole
Drug treatment
Other Names:
|
| Active Comparator: Caspofungin followed by Voriconazole |
Drug: Caspofungin
Drug treatment
Other Name: Cancidas
Drug: Voriconazole
Drug Treatment
Other Name: VFend
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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: NCT00413218
Show 113 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413218
Show 113 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica
Investigators
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00413218 History of Changes |
| Obsolete Identifiers: | NCT00444366 |
| Other Study ID Numbers: |
9766-CL-0105 WSA-CS-008 2006-003951-18 ( EudraCT Number ) |
| Study First Received: | December 18, 2006 |
| Last Updated: | September 2, 2015 |
Keywords provided by Astellas Pharma Inc:
|
Phase III study Isavuconazole Candidemia Invasive Candida infections |
Candidemia and other invasive candida infections ASP9766 BAL8557 |
Additional relevant MeSH terms:
|
Candidiasis Candidiasis, Invasive Infection Mycoses Candidemia Fungemia Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Voriconazole Caspofungin |
Echinocandins Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |
ClinicalTrials.gov processed this record on July 14, 2017