Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi (VICAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00634049
First received: March 5, 2008
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to investigate the safety and efficacy of isavuconazole in the treatment of invasive fungal infections that are caused by Aspergillus (in renally impaired patients)and rare fungi.


Condition Intervention Phase
Aspergillosis
Invasive Fungal Infections
Drug: isavuconazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Overall outcome of treatment evaluated by Data Review Committee (DRC) [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response


Secondary Outcome Measures:
  • Overall outcome of treatment evaluated by Investigator [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response

  • Overall outcome at end of treatment and Day 84 assessed by DRC and Investigator [ Time Frame: Day 84 and end of treatment (up to Day 180) ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response

  • Clinical response assessed by DRC and Investigator [ Time Frame: Day 42, Day 84, end of treatment (up to Day 180) and 4 weeks after last study dose ] [ Designated as safety issue: No ]
  • Mycological response by DRC and Investigator [ Time Frame: Day 42, Day 84, end of treatment (up to Day 180) and 4 weeks after last study dose ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: Day 42, Day 84, Day 120 and Day 180 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isavuconazole Drug: isavuconazole
Administration of 200mg isavuconazole three times a day iv or oral (in the vein or as a capsule for 2 days, followed by daily administration of 200mg isavuconazole iv or oral
Other Names:
  • ASP9766
  • BAL8557

Detailed Description:

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. Isavuconazole is not approved for the treatment of fungal infections. This study investigates the safety and efficacy of isavuconazole in patients with aspergillosis and renal impairment, and in patients suffering from invasive infections from rare fungi.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting EORTC/MSG (European Organization for the Research and Treatment of Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive fungal disease) caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.

OR

  • Patients who have proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.

Exclusion Criteria:

  • a known condition of the patient that may jeopardize adherence to the protocol requirements
  • Patients who are unlikely to survive 30 days
  • Patients with a body weight < 40 kg
  • Women who are pregnant or breastfeeding
  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: NCT00634049

  Show 98 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00634049     History of Changes
Other Study ID Numbers: 9766-CL-0103, WSA-CS-003, 2006-005003-33
Study First Received: March 5, 2008
Last Updated: September 30, 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
Egypt: Ministry of Health and Population
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Lebanon: Ministry of Public Health
Mexico: Secretaria de Salud
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Aspergillosis
invasive fungal infections caused by rare molds, rare yeasts
or by dimorphic fungi
Isavuconazole
ASP9766
BAL8557

Additional relevant MeSH terms:
Infection
Mycoses
Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014