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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00634049
Registration number
NCT00634049
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Titles & IDs
Public title
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
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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
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Secondary ID [1]
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0
WSA-CS-003
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Secondary ID [2]
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9766-CL-0103
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Universal Trial Number (UTN)
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Trial acronym
VITAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aspergillosis
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0
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Invasive Fungal Infections
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0
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Condition category
Condition code
Infection
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0
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0
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Other infectious diseases
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Infection
0
0
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
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Assessment method [1]
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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.
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Timepoint [1]
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Day 42, 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [1]
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Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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Assessment method [1]
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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.
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Timepoint [1]
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Day 42, 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [2]
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Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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Assessment method [2]
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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.
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Timepoint [2]
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Day 42, 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [3]
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Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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Assessment method [3]
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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.
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Timepoint [3]
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Day 42, 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [4]
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Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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Assessment method [4]
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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.
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Timepoint [4]
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Day 42, Day 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [5]
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Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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Assessment method [5]
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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.
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Timepoint [5]
0
0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [6]
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Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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Assessment method [6]
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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.
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Timepoint [6]
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Day 42, Day 84 and End of Treatment (EOT [Day 180])
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Secondary outcome [7]
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All-cause Mortality Through Day 42 and Day 84
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline to End of Treatment (EOT [Day 180])
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Secondary outcome [8]
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Safety - Overall Number of TEAEs
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Assessment method [8]
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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.
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Timepoint [8]
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From the first study drug administration until 28 days after the last dose of study drug
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/05/2016
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Sample size
Target
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Accrual to date
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Final
149
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Mater Medical Centre - South Brisbane
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Recruitment hospital [2]
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Princess Alexandria Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment outside Australia
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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St. Petersburg
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Gauteng
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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
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Inc
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Basilea Pharmaceutica International Ltd
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Address [1]
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00634049
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Astellas Pharma Global Development
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT00634049