Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
This study is currently recruiting participants.
Verified May 2013 by Astellas Pharma Inc
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: May 16, 2013
Last verified: May 2013
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Overall response [ Time Frame: 2 weeks after last study dose ] [ Designated as safety issue: No ]Resolution of signs and symptoms of infection plus mycological (presumed) eradication
Secondary Outcome Measures:
- Overall response assessment [ Time Frame: Day 7, end of treatment (up to Day 56), 6 weeks after last study drug ] [ Designated as safety issue: No ]
- Mycological response [ Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ] [ Designated as safety issue: No ]
- Clinical response [ Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug ] [ Designated as safety issue: No ]
- Time to first confirmed negative culture [ Time Frame: Up to 2 weeks after last study drug ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 526 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413218
Show 297 Study Locations
Contacts
| Contact: Astellas Pharma Global Development | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
Show 297 Study LocationsSponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica
Investigators
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| 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 |
| Study First Received: | December 18, 2006 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Chile: Instituto de Salud Publica de Chile China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Egypt: Ministry of Health and Population France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Israel: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Lebanon: Ministry of Public Health Mexico: Secretaria de Salud Malaysia: Ministry of Health New Zealand: Medsafe Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: The Central Register of Clinical Trials Russia: Ministry of Health of the Russian Federation Saudi Arabia: Ministry of Health Singapore: Health Sciences Authority South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Thailand: Food and Drug Administration Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines Switzerland: Swissmedic |
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 Mycoses Candidemia Candidiasis, Invasive Fungemia Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Voriconazole Caspofungin Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013