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

Primary Purpose

Candidiasis, Invasive, Candidemia, Mycoses

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

About this trial

This is an interventional treatment trial for Candidiasis, Invasive focused on measuring Invasive Candida infections, BAL8557, ASP9766, Isavuconazole, Candidemia, Candidemia and other invasive candida infections, Phase III study

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham
  • Somero Research Corporation
  • University of California Davis Health System
  • University of California at San Francisco
  • Idaho Falls Infectious Diseases PLLC
  • Loyola University Hospital
  • Springfield Clinic LLP
  • Infectious Disease of Indiana
  • Ochsner Clinic Foundation
  • University of Maryland School of Medicine
  • UMASS Memorial Medical Center
  • Henry Ford Hospital
  • Mercury Street Medical Group
  • Jersey Shore University Medical Center
  • New York Presbyterian Hospital
  • Wake Forest University Health Sciences
  • Regional Infection Diseases Infusion Center Inc.
  • Temple University Health Sciences
  • Hospital Britanico de Buenos Aires
  • Hospital General de Agudos Dr. Carlos G. Durand
  • Hospital Italiano de Buenos Aires
  • Instituto Medico Especializado Alexander Fleming
  • Hospital General de Agudos Dr. Cosme Argerich
  • Fremantle Hospital
  • Mater Adult Hospital
  • Westmead Hospital
  • Princess Alexandra Hospital
  • Institut Jules Bordet
  • Universitair Ziekenhuis Brussel
  • ULB Hôpital Erasme
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven
  • Hospital Felicio Rocho
  • Hospital das Clinicas da Universidade Federal de Minas Gerai
  • Santa Casa de Misericordia de Belo Horizonte
  • Hospital das Clinicas da UFPR
  • Hospital Nossa Senhora das Gracas
  • Hospital Sao Lucas - PUCRS
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Hospital Universitario Clementino Fraga Filho
  • Hospital Universitario de Santa Maria
  • Universidade Federal de Sao Paulo - UNIFESP
  • University of Alberta Hospital
  • Hamilton Health Sciences - Henderson Site
  • Queen's University
  • The Ottawa Hospital - General Campus
  • University Health Network - Toronto General Hospital
  • Hôpital Maisonneuve - Rosemont
  • Hospital Dr. Sotero del Rio
  • Hospital del Salvador
  • Hospital Dr. Hernan Henriquez Aravena
  • West China Hospital of Sichuan University
  • Huashan Hospital Fudan University
  • Hôpital Hautepierre
  • Hôpital de Brabois Adultes
  • Charite Campus Mitte
  • Universitaetsklinikum Freiburg
  • Universitaet Koeln
  • Klinikum St. Georg
  • Universitaetsklinik Leipzig
  • Universitaetsklinikum Leipzig
  • Universitaetsklinikum Wuerzburg
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Petz Aladar Megyei Oktato Korhaz
  • Max Super Speciality Hospital
  • Metro Centre for Respiratory Diseases
  • Kasturba Medical College and Hospital
  • Kasturba Medical College K. M. C. Hospital
  • Amrita Institute Of Medical Science
  • Deenanath Mangeshkar Hospital and Research Centre
  • Apollo Hospitals Educational & Research Foundation
  • Nizam's Institute of Medical Sciences
  • AMRI Hospital
  • Christian Medical College & Hospital
  • Ha Emek Medical Center
  • Rambam Health Care Campus
  • Wolfson Medical Center
  • Hadassah Universtiy Hospital - Ein Kerem
  • Sapir Medical Center, Meir Hospital
  • Rabin MC
  • Chaim Sheba Medical Center
  • Sourasky MC Ichilov Hospital Tel Aviv
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Ente Ospedaliero Ospedeli Galliera
  • Azienda Ospedaliero Universitaria San Martino
  • Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
  • AUB Medical Center
  • Rafik Hariri Uni Hospital
  • Hospital Ampang
  • Pusat Perubatan Universiti Kebangsaan Malaysia
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Hospital Civil de Guadalajara Dr Juan I Menchaca
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Auckland City Hospital
  • Waikato Urology Research Ltd
  • De La Salle Health Sciences Institute- DLSUMC
  • Philippine General Hospital
  • S.I. Russian Oncological Research Center n.a. N.N. Blokhin
  • State Institution "Hematology Research Center" RAMS
  • Singapore General Hospital - Parent
  • National Neuroscience Institute
  • Unitas Hospital
  • Hospital del Mar
  • Hôpitaux Universitaires de Genève - HUG
  • Universitaetsspital Zuerich
  • Siriraj Hospital
  • Songklanagarind Hospital
  • Maharat Nakhon Ratchasima Hospital
  • Srinagarind Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isavuconazole (ISA)

Caspofungin (CAS)/Voriconazole

Arm Description

Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.

Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Outcomes

Primary Outcome Measures

Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use
A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.

Secondary Outcome Measures

Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.
Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).
Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).
Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).
Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
Success was defined as mycological response (eradication or presumed eradication).
Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.
All-Cause Mortality (ACM) at Day 14 and Day 56
All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.
Time to First Confirmed Negative Culture
The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis

Full Information

First Posted
December 18, 2006
Last Updated
January 31, 2019
Sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica
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1. Study Identification

Unique Protocol Identification Number
NCT00413218
Brief Title
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Official Title
A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2007 (Actual)
Primary Completion Date
March 3, 2015 (Actual)
Study Completion Date
March 3, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Invasive, Candidemia, Mycoses
Keywords
Invasive Candida infections, BAL8557, ASP9766, Isavuconazole, Candidemia, Candidemia and other invasive candida infections, Phase III study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isavuconazole (ISA)
Arm Type
Experimental
Arm Description
Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
Arm Title
Caspofungin (CAS)/Voriconazole
Arm Type
Active Comparator
Arm Description
Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
Intervention Type
Drug
Intervention Name(s)
Isavuconazole
Other Intervention Name(s)
ASP9766, BAL8557
Intervention Description
Administered by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Other Intervention Name(s)
Cancidas
Intervention Description
Administered by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Other Intervention Name(s)
VFend
Intervention Description
Administered by intravenous infusion.
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use
Description
A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.
Time Frame
End of Intravenous Treatment (EOIV) (Days 11-56)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)
Description
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.
Time Frame
End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)
Title
Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2
Description
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).
Time Frame
EOT (Day 56) and FU2 (6 weeks after end of treatment)
Title
Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Description
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).
Time Frame
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Title
Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Description
A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).
Time Frame
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Title
Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
Description
Success was defined as mycological response (eradication or presumed eradication).
Time Frame
Day 7 and EOT (Day 56)
Title
Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
Description
Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.
Time Frame
Day 7 and EOT (Day 56)
Title
All-Cause Mortality (ACM) at Day 14 and Day 56
Description
All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.
Time Frame
Day 14 and Day 56
Title
Time to First Confirmed Negative Culture
Description
The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis
Time Frame
Day 1 up to FU1 (2 weeks after EOT (Day 56))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
35294-0006
Country
United States
Facility Name
Somero Research Corporation
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
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
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Idaho Falls Infectious Diseases PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Loyola University Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Springfield Clinic LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
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
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
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
Hospital Britanico de Buenos Aires
City
Capital Federal
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Hospital General de Agudos Dr. Carlos G. Durand
City
Capital Federal
ZIP/Postal Code
C1405DCS
Country
Argentina
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 General de Agudos Dr. Cosme Argerich
City
La Boca
ZIP/Postal Code
1157
Country
Argentina
Facility Name
Fremantle Hospital
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
ULB Hôpital Erasme
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
Hospital das Clinicas da Universidade Federal de Minas Gerai
City
Belo Horizonte
ZIP/Postal Code
30130-100
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 Nossa Senhora das Gracas
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
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
Universidade Federal de Sao Paulo - UNIFESP
City
São Paulo
ZIP/Postal Code
04020-002
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Hamilton Health Sciences - Henderson Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hospital Dr. Sotero del Rio
City
Puente Alto Santiago
Country
Chile
Facility Name
Hospital del Salvador
City
Santiago
Country
Chile
Facility Name
Hospital Dr. Hernan Henriquez Aravena
City
Temuco
ZIP/Postal Code
4780000
Country
Chile
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67048
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitaet Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Universitaetsklinik Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Luebeck
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Max Super Speciality Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Metro Centre for Respiratory Diseases
City
Noida
State/Province
Delhi
ZIP/Postal Code
201301
Country
India
Facility Name
Kasturba Medical College and Hospital
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Kasturba Medical College K. M. C. Hospital
City
Manipal
State/Province
Karna
ZIP/Postal Code
576104
Country
India
Facility Name
Amrita Institute Of Medical Science
City
Cochin
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
Facility Name
Apollo Hospitals Educational & Research Foundation
City
Chennai
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
AMRI Hospital
City
Kolkata
ZIP/Postal Code
700098
Country
India
Facility Name
Christian Medical College & Hospital
City
Vellore Tamilnadu
Country
India
Facility Name
Ha Emek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadassah Universtiy Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Sapir Medical Center, Meir Hospital
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin MC
City
Petah
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
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25126
Country
Italy
Facility Name
Ente Ospedaliero Ospedeli Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
AUB Medical Center
City
Beirut
ZIP/Postal Code
11-0236
Country
Lebanon
Facility Name
Rafik Hariri Uni Hospital
City
Beirut
ZIP/Postal Code
5244
Country
Lebanon
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Dr Juan I Menchaca
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
City
Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Waikato Urology Research Ltd
City
Hamilton
Country
New Zealand
Facility Name
De La Salle Health Sciences Institute- DLSUMC
City
Cavite City
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
Country
Philippines
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
Singapore General Hospital - Parent
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Neuroscience Institute
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Unitas Hospital
City
Lyttelton Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hôpitaux Universitaires de Genève - HUG
City
Geneva
Country
Switzerland
Facility Name
Universitaetsspital Zuerich
City
Zurich
Country
Switzerland
Facility Name
Siriraj Hospital
City
Bangkoknoi
ZIP/Postal Code
10700
Country
Thailand
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
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
30289478
Citation
Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.
Results Reference
derived
PubMed Identifier
25902926
Citation
McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=295
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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