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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00413218




Registration number
NCT00413218
Ethics application status
Date submitted
18/12/2006
Date registered
19/12/2006

Titles & IDs
Public title
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Scientific 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
Secondary ID [1] 0 0
WSA-CS-008
Secondary ID [2] 0 0
9766-CL-0105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Candidiasis, Invasive 0 0
Candidemia 0 0
Mycoses 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Isavuconazole
Treatment: Drugs - Caspofungin
Treatment: Drugs - Voriconazole

Experimental: Isavuconazole (ISA) - 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.

Active comparator: Caspofungin (CAS)/Voriconazole - 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.


Treatment: Drugs: Isavuconazole
Administered by intravenous infusion.

Treatment: Drugs: Caspofungin
Administered by intravenous infusion.

Treatment: Drugs: Voriconazole
Administered by intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
End of Intravenous Treatment (EOIV) (Days 11-56)
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
EOT (Day 56) and FU2 (6 weeks after end of treatment)
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Timepoint [3] 0 0
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Secondary outcome [4] 0 0
Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Timepoint [4] 0 0
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Secondary outcome [5] 0 0
Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
Timepoint [5] 0 0
Day 7 and EOT (Day 56)
Secondary outcome [6] 0 0
Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
Timepoint [6] 0 0
Day 7 and EOT (Day 56)
Secondary outcome [7] 0 0
All-Cause Mortality (ACM) at Day 14 and Day 56
Timepoint [7] 0 0
Day 14 and Day 56
Secondary outcome [8] 0 0
Time to First Confirmed Negative Culture
Timepoint [8] 0 0
Day 1 up to FU1 (2 weeks after EOT (Day 56))

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/03/2015
Sample size
Target
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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California
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Idaho
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Illinois
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Montana
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Pennsylvania
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Capital Federal
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Argentina
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La Boca
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Brussels
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Chile
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Györ
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Delhi
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Kerala
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Mahara
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Vellore Tamilnadu
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Afula
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Holon
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Jerusalem
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Kfar-Saba
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Petah
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Bologna
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Brescia
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Genova
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Italy
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Verona
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Lebanon
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Beirut
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Ampang
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Malaysia
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Kuala Lumpur
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Auckland
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Hamilton
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Philippines
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Cavite City
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Philippines
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Manila
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Russian Federation
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Moscow
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Barcelona
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Geneva
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Zurich
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Bangkoknoi
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Hat Yai
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Thailand
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Muang
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Thailand
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Ratchathewi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Basilea Pharmaceutica
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00413218