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: June 2, 2014
Last verified: June 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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
City Of Hope National Medical Center
Duarte, California, United States, 91010
University of California Davis Health System
Sacramento, California, United States, 95817
California Pacific Medical Center
San Francisco, California, United States, 94110
University of California at San Francisco
San Francisco, California, United States, 94143
Stanford University Hospital
Stanford, California, United States, 94303
United States, Colorado
University Of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana BMT
Beech Grove, Indiana, United States, 46107
Infectious Disease of Indiana
Indianapolis, Indiana, United States, 46280
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Upstate Infectious Diseases Association LLP
Albany, New York, United States, 12208
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, United States, 45801
United States, Pennsylvania
Temple University Health Sciences
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center, Clinical Research
Seattle, Washington, United States, 98109
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma, Argentina, 1181
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, Argentina, 1426
Hospital San Roque
Cordoba, Argentina, 5000
Hospital Nuestra Senora de la Misericordia
Cordoba, Argentina, 5000
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, Argentina, 5402
Australia
Mater Medical Centre
South Brisbane, Australia, 4101
Princess Alexandria Hospital
Woolloongabba, Australia, 4102
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Erasme Hospital
Bruxelles, Belgium, 1070
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Brazil
Hospital Felicio Rocho
Belo Horizonte, Brazil, 30110-908
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Brazil, 30150-221
Hospital das Clinicas da UFPR
Curitiba, Brazil, 80060-150
Hospital de Clinicas da FMUSP - Ribeirao Preto
Ribeirao Preto, Brazil, 14048-900
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, Brazil, 21941-913
Hospital Universitario de Santa Maria
Santa Maria, Brazil, 97105-900
Hospital Professor Edmundo Vasconcelos
São Paulo, Brazil, 04038-905
Canada, Ontario
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, Canada, L8V 1C3
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hôpital Maisonneuve - Rosemont
Montréal, Quebec, Canada, H1T 2M4
Chile
Hospital Clinico San Borja Arriaran
Santiago, Chile, 8320000
Egypt
Alexandria University Hospital
Alexandria, Egypt, 21131
National Cancer Institute
Cairo, Egypt, 11796
Nasser Institute
Cairo, Egypt, 12655
France
Hôpital Edouard Herriot
Lyon cedex 3, France, 69437
Institut Paoli Calmette - Marseille
Marseille Cedex 9, France, 13273
Hotel Dieu
Nantes, France, 44093
Hôpital Saint-Louis
Paris Cedex 10, France, 75475
Hopital Hautepierre
Strasbourg Cedex, France, 67048
Hôpital de brabois adultes
Vandoeuvre les Nancy, France, 54511
Germany
Universitaetsklinikum Aachen
Aachen, Germany, 52074
Charité Universitaetsmedizin Berlin- Campus Charité Mitte
Berlin, Germany, 12200
Universitaet Koeln
Köln, Germany, 50931
Klinikum Neuperlach
Muenchen, Germany, 81737
Medizinische klinik und Polyklinik II
Würzburg, Germany, 97080
India
Medanta Medicity Hospital
Gurgaon, Haryan, India, 122001
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
Manipal, Kama, India, 576104
Tata Memorial Hopital, Department of Anesthesia
Mumbai, Mahara, India, 400012
Deenanath Mangeshkar Hospital & Research Centre
Pune, Mahara, India, 411004
Global Hospitals & Health City
Chennai, Tamilna, India, 600100
Sterling Hospital
Ahmedabad, India, 380052
Apollo Hospitals
Hyderabad, India, 500033
Sahyadri Specialty Hospital
Pune, India, 411004
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, Israel, 91200
Rabin MC
Petah Tikva, Israel, 49100
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, Israel, 64239
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Buchon-si, Korea, Republic of, 420-767
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon, 11-0236
Clinique Dr. Rizk
Beirut, Lebanon, 1107-2130
Rafik Hariri University Hospital
Beirut, Lebanon, 5244
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico, 44280
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
Mexico City, Mexico, 14000
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Mexico, 64460
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi, Mexico, 78240
Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland, 02097
Russian Federation
State Institution "Hematology Research Center" RAMS
Moscow, Russian Federation, 125167
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
Republican Hospital named after V.A. Baranov
Petrozavodsk, Russian Federation, 185019
St-Petersburg MA Postgraduate Education
St. Petersburg, Russian Federation, 194291
South Africa
Dr H J van Rensburg
Lyttleton, Gauteng, South Africa, 0157
Thailand
Songklanagarind Hospital
Hat Yai, Thailand, 90110
Maharaj Nakorn Chiang Mai Hospital
Muang, Thailand, 50200
Maharat Nakhon Ratchasima Hospital
Muang, Thailand, 30000
Srinagarind Hospital
Muang, Thailand, 40002
Ramathibodi Hospital
Ratchathewi, Thailand, 10400
United Kingdom
University of Manchester
Manchester, United Kingdom, M13 9PT
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: June 2, 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 September 22, 2014