Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Astellas Pharma Inc
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00413218
First received: December 18, 2006
Last updated: June 26, 2014
Last verified: June 2014
  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 at end of intravenous (IV) therapy [ Time Frame: Up to the maximum duration of therapy of 56 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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: July 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isavuconazole Drug: Isavuconazole
Drug treatment
Other Names:
  • ASP9766
  • BAL8557
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
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

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

  Show 297 Study Locations
Sponsors 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: June 26, 2014
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 Pública 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: The Italian Medicines Agency
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: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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: Agencia Española de Medicamentos y Productos Sanitarios
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
Candidiasis, Invasive
Mycoses
Candidemia
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 July 29, 2014