Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/ct2/show/NCT00634049




Registration number
NCT00634049
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
2/01/2018

Titles & IDs
Public title
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Scientific 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
Secondary ID [1] 0 0
WSA-CS-003
Secondary ID [2] 0 0
9766-CL-0103
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspergillosis 0 0
Invasive Fungal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

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

Experimental: Isavuconazole - 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


Treatment: Drugs: isavuconazole
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
Timepoint [1] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [1] 0 0
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [1] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [2] 0 0
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [2] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [3] 0 0
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [3] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [4] 0 0
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [4] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [5] 0 0
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [5] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [6] 0 0
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [6] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [7] 0 0
All-cause Mortality Through Day 42 and Day 84
Timepoint [7] 0 0
Baseline to End of Treatment (EOT [Day 180])
Secondary outcome [8] 0 0
Safety - Overall Number of TEAEs
Timepoint [8] 0 0
From the first study drug administration until 28 days after the last dose of study drug

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
22/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/05/2016
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mater Medical Centre - South Brisbane
Recruitment hospital [2] 0 0
Princess Alexandria Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
San Juan
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Brazil
State/province [23] 0 0
Belo Horizonte
Country [24] 0 0
Brazil
State/province [24] 0 0
Curitiba
Country [25] 0 0
Brazil
State/province [25] 0 0
Ribeirao Preto
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio de Janeiro
Country [27] 0 0
Brazil
State/province [27] 0 0
Santa Maria
Country [28] 0 0
Brazil
State/province [28] 0 0
São Paulo
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Santiago
Country [32] 0 0
Egypt
State/province [32] 0 0
Alexandria
Country [33] 0 0
Egypt
State/province [33] 0 0
Cairo
Country [34] 0 0
France
State/province [34] 0 0
Lyon cedex 3
Country [35] 0 0
France
State/province [35] 0 0
Marseille Cedex 9
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Paris Cedex 10
Country [38] 0 0
France
State/province [38] 0 0
Strasbourg Cedex
Country [39] 0 0
France
State/province [39] 0 0
Vandoeuvre les Nancy
Country [40] 0 0
Germany
State/province [40] 0 0
Aachen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Köln
Country [43] 0 0
Germany
State/province [43] 0 0
Muenchen
Country [44] 0 0
Germany
State/province [44] 0 0
Würzburg
Country [45] 0 0
India
State/province [45] 0 0
Haryan
Country [46] 0 0
India
State/province [46] 0 0
Kama
Country [47] 0 0
India
State/province [47] 0 0
Mahara
Country [48] 0 0
India
State/province [48] 0 0
Tamilna
Country [49] 0 0
India
State/province [49] 0 0
Ahmedabad
Country [50] 0 0
India
State/province [50] 0 0
Hyderabad
Country [51] 0 0
India
State/province [51] 0 0
Pune
Country [52] 0 0
Israel
State/province [52] 0 0
Haifa
Country [53] 0 0
Israel
State/province [53] 0 0
Jerusalem
Country [54] 0 0
Israel
State/province [54] 0 0
Petah Tikva
Country [55] 0 0
Israel
State/province [55] 0 0
Ramat-Gan
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Aviv
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Buchon-si
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Incheon
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Lebanon
State/province [60] 0 0
Beirut
Country [61] 0 0
Mexico
State/province [61] 0 0
Guadalajara
Country [62] 0 0
Mexico
State/province [62] 0 0
Mexico City
Country [63] 0 0
Mexico
State/province [63] 0 0
Monterrey
Country [64] 0 0
Mexico
State/province [64] 0 0
San Luis Potosi
Country [65] 0 0
Poland
State/province [65] 0 0
Warszawa
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Petrozavodsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
Country [69] 0 0
South Africa
State/province [69] 0 0
Gauteng
Country [70] 0 0
Thailand
State/province [70] 0 0
Hat Yai
Country [71] 0 0
Thailand
State/province [71] 0 0
Muang
Country [72] 0 0
Thailand
State/province [72] 0 0
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 International Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00634049
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