Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00412893
Registration number
NCT00412893
Ethics application status
Date submitted
18/12/2006
Date registered
19/12/2006
Titles & IDs
Public title
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Query!
Scientific title
A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
Query!
Secondary ID [1]
0
0
WSA-CS-004
Query!
Secondary ID [2]
0
0
9766-CL-0104
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Aspergillosis
0
0
Query!
Invasive Fungal Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Isavuconazole
Treatment: Drugs - Voriconazole
Experimental: Isavuconazole - Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
Active comparator: Voriconazole - Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Treatment: Drugs: Isavuconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Treatment: Drugs: Voriconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
All-cause Mortality Through Day 42
Query!
Assessment method [1]
0
0
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.
Query!
Timepoint [1]
0
0
Through Day 42
Query!
Secondary outcome [1]
0
0
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
Query!
Assessment method [1]
0
0
The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.
Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a \> 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).
End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death.
Query!
Timepoint [1]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [2]
0
0
All-cause Mortality Through Day 84
Query!
Assessment method [2]
0
0
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.
Query!
Timepoint [2]
0
0
Through Day 84
Query!
Secondary outcome [3]
0
0
Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator
Query!
Assessment method [3]
0
0
Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).
Query!
Timepoint [3]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [4]
0
0
Percentage of Participants With a Clinical Response Assessed by the DRC
Query!
Assessment method [4]
0
0
Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Query!
Timepoint [4]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [5]
0
0
Percentage of Participants With a Mycological Response Assessed by the DRC
Query!
Assessment method [5]
0
0
Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as "Not Applicable".
End of treatment is the last day of study drug administration.
Query!
Timepoint [5]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [6]
0
0
Percentage of Participants With a Radiological Response Assessed by the DRC
Query!
Assessment method [6]
0
0
Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.
Radiological response is defined as a = 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Query!
Timepoint [6]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [7]
0
0
Percentage of Participants With a Clinical Response Assessed by the Investigator
Query!
Assessment method [7]
0
0
Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Query!
Timepoint [7]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [8]
0
0
Percentage of Participants With a Mycological Response Assessed by the Investigator
Query!
Assessment method [8]
0
0
Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as "Not Applicable".
End of treatment is the last day of study drug administration.
Query!
Timepoint [8]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [9]
0
0
Percentage of Participants With a Radiological Response Assessed by the Investigator
Query!
Assessment method [9]
0
0
Radiological assessments were performed by the investigator. Radiological response is defined as a = 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a \< 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Query!
Timepoint [9]
0
0
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Query!
Secondary outcome [10]
0
0
Number of Participants With Adverse Events, Reported by System Organ Class
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.
Query!
Eligibility
Key inclusion criteria
* Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi
* Female patients must be non-lactating and at no risk for pregnancy
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
* Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
* Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis
* Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication
* Patients previously enrolled in a Phase III study with isavuconazole
* Patients with a body weight </= 40 kg
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/03/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/03/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
527
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Perth
Query!
Recruitment hospital [2]
0
0
Mater Medical Centre - South Brisbane
Query!
Recruitment hospital [3]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Buenos Aires
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Capital Federal
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Ciudad Autonoma
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Brugge
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Brussels
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Bruxelles
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Gent
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Leuven
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Belo Horizonte
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Curitiba
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Ribeirão Preto
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Rio de Janeiro
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Hamilton
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Santiago
Query!
Country [24]
0
0
Chile
Query!
State/province [24]
0
0
Temuco
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Valdivia
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Beijing
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Changchun
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Changsha
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Chengdu
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Fuzhou
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Hangzhou
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Nanjing
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Nanning
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Shanghai
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Wuhan
Query!
Country [36]
0
0
Egypt
Query!
State/province [36]
0
0
Alexandria
Query!
Country [37]
0
0
Egypt
Query!
State/province [37]
0
0
Cairo
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Dijon
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Nantes Cedex 01
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Nantes Cedex
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Strasbourg
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Vandoeuvre les Nancy
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Aachen
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Berlin
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Köln
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Leipzig
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Luebeck
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Muenchen
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Würzburg
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Györ
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Szeged
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Andh Prad
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
Gujarat
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Karna
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
Mahara
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
Uttar Prad
Query!
Country [58]
0
0
Israel
Query!
State/province [58]
0
0
Haifa
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Jerusalem
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Petah Tikva
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Ramat-Gan
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Tel Aviv
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Firenze
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Milano
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Incheon
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Malaysia
Query!
State/province [67]
0
0
Kuala Lumpur
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Mexico
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Monterrey
Query!
Country [70]
0
0
Netherlands
Query!
State/province [70]
0
0
Nijmegen
Query!
Country [71]
0
0
New Zealand
Query!
State/province [71]
0
0
Palmerston North
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Warszawa
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Moscow
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Petrozavodsk
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
St. Petersburg
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Salamanca
Query!
Country [77]
0
0
Switzerland
Query!
State/province [77]
0
0
Zurich
Query!
Country [78]
0
0
Thailand
Query!
State/province [78]
0
0
Hat Yai
Query!
Country [79]
0
0
Thailand
Query!
State/province [79]
0
0
Khon Kaen
Query!
Country [80]
0
0
Thailand
Query!
State/province [80]
0
0
Muang
Query!
Country [81]
0
0
Thailand
Query!
State/province [81]
0
0
Songkla
Query!
Country [82]
0
0
Turkey
Query!
State/province [82]
0
0
Istanbul
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Astellas Pharma Inc
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Basilea Pharmaceutica International Ltd
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00412893
Query!
Trial related presentations / publications
Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433. doi: 10.1093/cid/cix563. Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Astellas Pharma Global Development
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/
Query!
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 not provided in
https://clinicaltrials.gov/study/NCT00412893