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

Primary Purpose

Aspergillosis, Invasive Fungal Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
isavuconazole
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis focused on measuring invasive fungal infections caused by rare molds, rare yeasts, BAL8557, Isavuconazole, Aspergillosis, or by dimorphic fungi, ASP9766

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•Participants 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 moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.

OR

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

OR

•Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were refractory to current treatment defined as,

  • Clear documentation of progression of disease. Note: radiological progression only in association with white blood cell (WBC) count recovery was not acceptable.
  • Failure to improve clinically despite receiving at least 7 days of standard antifungal regimen. Prior to enrolling patients who fell into this category, the Medical Monitor was contacted for approval.

OR

• Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were intolerant to current treatment for example:

  • Doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours.
  • Serum creatinine > 2.0 mg/mL and current treatment with polyene or IV voriconazole.
  • Other significant drug-related adverse reaction(s) to the current antifungal agent, resulting in discontinuation of the treatment, e.g., persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction (hypertensive crisis, severe chills or shock).
  • Documented inability to achieve adequate blood levels of posaconazole, voriconazole or itraconazole.

Exclusion Criteria:

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

Sites / Locations

  • University of Alabama at Birmingham
  • City Of Hope National Medical Center
  • University of California Davis Health System
  • California Pacific Medical Center
  • University of California at San Francisco
  • Stanford University Hospital
  • University Of Colorado Health Sciences Center
  • Emory Hospital
  • University of Chicago, Division of Infectious Diseases
  • Indiana BMT
  • Infectious Disease of Indiana
  • Ochsner Clinic Foundation
  • Brigham & Womens Hospital
  • UMASS Memorial Medical Center
  • Wayne State University School of Medicine
  • Henry Ford Hospital
  • University of Minnesota
  • Upstate Infectious Diseases Association LLP
  • Cleveland Clinic
  • Regional Infection Diseases Infusion Center Inc.
  • Temple University Health Sciences
  • University of Pittsburgh Medical Center Health System
  • University of Texas MD Anderson Cancer Center
  • Fred Hutchinson Cancer Research Center, Clinical Research
  • Hospital Italiano de Buenos Aires
  • Instituto Medico Especializado Alexander Fleming
  • Hospital Nuestra Senora de la Misericordia
  • Hospital San Roque
  • Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
  • Mater Medical Centre
  • Princess Alexandria Hospital
  • Institut Jules Bordet
  • Erasme Hospital
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven
  • Hospital Felicio Rocho
  • Santa Casa de Misericordia de Belo Horizonte
  • Hospital das Clinicas da UFPR
  • Hospital de Clinicas da FMUSP - Ribeirao Preto
  • Hospital Universitario Clementino Fraga Filho
  • Hospital Universitario de Santa Maria
  • Hospital Professor Edmundo Vasconcelos
  • Hamilton Health Sciences - Henderson Site
  • The Ottawa Hospital - General Campus
  • Hôpital Maisonneuve - Rosemont
  • Hôpital Maisonneuve - Rosemont
  • Hospital Clinico San Borja Arriaran
  • Alexandria University Hospital
  • National Cancer Institute
  • Nasser Institute
  • Hôpital Edouard Herriot
  • Institut Paoli Calmette - Marseille
  • Hotel Dieu
  • Hôpital Saint-Louis
  • Hopital Hautepierre
  • Hôpital de Brabois Adultes
  • Universitaetsklinikum Aachen
  • Charite-Campus Benjamin Franklin
  • Universitaet Koeln
  • Klinikum Neuperlach
  • Medizinische Klinik und Polyklinik II
  • Medanta Medicity Hospital
  • Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
  • Tata Memorial Hopital, Department of Anesthesia
  • Deenanath Mangeshkar Hospital & Research Centre
  • Global Hospitals & Health City
  • Sterling Hospital
  • Apollo Hospitals
  • Sahyadri Specialty Hospital
  • Rambam Health Care Campus
  • Hadassah Universtiy Hospital - Ein Kerem
  • Rabin MC
  • Chaim Sheba Medical Center
  • Sourasky MC Ichilov Hospital Tel Aviv
  • Soonchunhyang University Bucheon Hospital
  • Gachon University Gil Hospital
  • Samsung Medical Center
  • The Catholic University of Korea
  • Asan Medical Center
  • American University of Beirut Medical Center
  • Clinique Dr. Rizk
  • Rafik Hariri University Hospital
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Hospital Central Dr Ignacio Morones Prieto
  • Samodzielny Publiczny Centralny Szpital Kliniczny
  • S.I. Russian Oncological Research Center n.a. N.N. Blokhin
  • State Institution "Hematology Research Center" RAMS
  • Republican Hospital named after V.A. Baranov
  • St-Petersburg MA Postgraduate Education
  • Private Practice
  • Songklanagarind Hospital
  • Maharat Nakhon Ratchasima Hospital
  • Srinagarind Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Ramathibodi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Isavuconazole

Arm Description

Administration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral

Outcomes

Primary Outcome Measures

Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Secondary Outcome Measures

Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
All-cause Mortality Through Day 42 and Day 84
All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Safety - Overall Number of TEAEs
A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.

Full Information

First Posted
March 5, 2008
Last Updated
December 7, 2017
Sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica International Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00634049
Brief Title
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Acronym
VITAL
Official Title
Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 22, 2008 (Actual)
Primary Completion Date
January 3, 2014 (Actual)
Study Completion Date
May 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica International Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.
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. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Invasive Fungal Infections
Keywords
invasive fungal infections caused by rare molds, rare yeasts, BAL8557, Isavuconazole, Aspergillosis, or by dimorphic fungi, ASP9766

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isavuconazole
Arm Type
Experimental
Arm Description
Administration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral
Intervention Type
Drug
Intervention Name(s)
isavuconazole
Other Intervention Name(s)
BAL8557, ASP9766
Intervention Description
Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral
Primary Outcome Measure Information:
Title
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
Description
The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary Outcome Measure Information:
Title
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Description
The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, 84 and End of Treatment (EOT [Day 180])
Title
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Description
The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, 84 and End of Treatment (EOT [Day 180])
Title
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Description
The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, 84 and End of Treatment (EOT [Day 180])
Title
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Description
The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Title
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Description
The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Title
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Description
The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Title
All-cause Mortality Through Day 42 and Day 84
Description
All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Time Frame
Baseline to End of Treatment (EOT [Day 180])
Title
Safety - Overall Number of TEAEs
Description
A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.
Time Frame
From the first study drug administration until 28 days after the last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: •Participants 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 moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment. OR •Participants who had proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology. OR •Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were refractory to current treatment defined as, Clear documentation of progression of disease. Note: radiological progression only in association with white blood cell (WBC) count recovery was not acceptable. Failure to improve clinically despite receiving at least 7 days of standard antifungal regimen. Prior to enrolling patients who fell into this category, the Medical Monitor was contacted for approval. OR • Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were intolerant to current treatment for example: Doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours. Serum creatinine > 2.0 mg/mL and current treatment with polyene or IV voriconazole. Other significant drug-related adverse reaction(s) to the current antifungal agent, resulting in discontinuation of the treatment, e.g., persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction (hypertensive crisis, severe chills or shock). Documented inability to achieve adequate blood levels of posaconazole, voriconazole or itraconazole. Exclusion Criteria: A known condition of the participants that may jeopardize adherence to the protocol requirements Participants who are unlikely to survive 30 days Participants with a body weight < 40 kg Women who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City Of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University Of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago, Division of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana BMT
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Brigham & Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Upstate Infectious Diseases Association LLP
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Regional Infection Diseases Infusion Center Inc.
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Temple University Health Sciences
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center, Clinical Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autonoma
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Nuestra Senora de la Misericordia
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital San Roque
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
City
San Juan
ZIP/Postal Code
5402
Country
Argentina
Facility Name
Mater Medical Centre
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandria Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Erasme Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Felicio Rocho
City
Belo Horizonte
ZIP/Postal Code
30110-908
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital das Clinicas da UFPR
City
Curitiba
ZIP/Postal Code
80060-150
Country
Brazil
Facility Name
Hospital de Clinicas da FMUSP - Ribeirao Preto
City
Ribeirao Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Universitario de Santa Maria
City
Santa Maria
ZIP/Postal Code
97105-900
Country
Brazil
Facility Name
Hospital Professor Edmundo Vasconcelos
City
São Paulo
ZIP/Postal Code
04038-905
Country
Brazil
Facility Name
Hamilton Health Sciences - Henderson Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hospital Clinico San Borja Arriaran
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Alexandria University Hospital
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Nasser Institute
City
Cairo
ZIP/Postal Code
12655
Country
Egypt
Facility Name
Hôpital Edouard Herriot
City
Lyon cedex 3
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmette - Marseille
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Hautepierre
City
Strasbourg Cedex
ZIP/Postal Code
67048
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite-Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitaet Koeln
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Klinikum Neuperlach
City
Muenchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Medizinische Klinik und Polyklinik II
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Medanta Medicity Hospital
City
Gurgaon
State/Province
Haryan
ZIP/Postal Code
122001
Country
India
Facility Name
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
City
Manipal
State/Province
Kama
ZIP/Postal Code
576104
Country
India
Facility Name
Tata Memorial Hopital, Department of Anesthesia
City
Mumbai
State/Province
Mahara
ZIP/Postal Code
400012
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
Facility Name
Global Hospitals & Health City
City
Chennai
State/Province
Tamilna
ZIP/Postal Code
600100
Country
India
Facility Name
Sterling Hospital
City
Ahmedabad
ZIP/Postal Code
380052
Country
India
Facility Name
Apollo Hospitals
City
Hyderabad
ZIP/Postal Code
500033
Country
India
Facility Name
Sahyadri Specialty Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Universtiy Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Rabin MC
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky MC Ichilov Hospital Tel Aviv
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Soonchunhyang University Bucheon Hospital
City
Buchon-si
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
11-0236
Country
Lebanon
Facility Name
Clinique Dr. Rizk
City
Beirut
ZIP/Postal Code
1107-2130
Country
Lebanon
Facility Name
Rafik Hariri University Hospital
City
Beirut
ZIP/Postal Code
5244
Country
Lebanon
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Central Dr Ignacio Morones Prieto
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02097
Country
Poland
Facility Name
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Institution "Hematology Research Center" RAMS
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Republican Hospital named after V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
St-Petersburg MA Postgraduate Education
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Private Practice
City
Lyttleton
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Maharat Nakhon Ratchasima Hospital
City
Muang
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Citations:
PubMed Identifier
27185799
Citation
Kovanda LL, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate P, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study). Antimicrob Agents Chemother. 2016 Jul 22;60(8):4568-76. doi: 10.1128/AAC.00514-16. Print 2016 Aug.
Results Reference
derived
PubMed Identifier
27169478
Citation
Thompson GR 3rd, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, Ostrosky-Zeichner L, Azie N, Maher R, Lee M, Kovanda L, Engelhardt M, Vazquez JA, Cornely OA, Perfect JR. Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses. Clin Infect Dis. 2016 Aug 1;63(3):356-62. doi: 10.1093/cid/ciw305. Epub 2016 May 11.
Results Reference
derived
PubMed Identifier
26969258
Citation
Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Racil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=51
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

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