Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
VITAL
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
3 other identifiers
interventional
149
19 countries
96
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Longer than P75 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2008
CompletedStudy Start
First participant enrolled
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2014
CompletedResults Posted
Study results publicly available
January 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2016
CompletedDecember 11, 2024
November 1, 2024
5.7 years
March 5, 2008
December 2, 2015
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
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.
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary Outcomes (8)
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42, 84 and End of Treatment (EOT [Day 180])
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42, 84 and End of Treatment (EOT [Day 180])
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42, 84 and End of Treatment (EOT [Day 180])
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 42, Day 84 and End of Treatment (EOT [Day 180])
- +3 more secondary outcomes
Study Arms (1)
Isavuconazole
EXPERIMENTALAdministration 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Basilea Pharmaceutica International Ltdcollaborator
Study Sites (96)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City Of Hope National Medical Center
Duarte, California, 91010, United States
University of California Davis Health System
Sacramento, California, 95817, United States
California Pacific Medical Center
San Francisco, California, 94110, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Stanford University Hospital
Stanford, California, 94303, United States
University Of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Emory Hospital
Atlanta, Georgia, 30322, United States
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, 60637, United States
Indiana BMT
Beech Grove, Indiana, 46107, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46280, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Brigham & Womens Hospital
Boston, Massachusetts, 02115, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Wayne State University School of Medicine
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Upstate Infectious Diseases Association LLP
Albany, New York, 12208, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, 45801, United States
Temple University Health Sciences
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center, Clinical Research
Seattle, Washington, 98109, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma, 1181, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, 1426, Argentina
Hospital Nuestra Senora de la Misericordia
Córdoba, 5000, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
Centro Polivalente de Asistencia e Investigación ClÃnica - CER San Juan
San Juan, 5402, Argentina
Mater Medical Centre
South Brisbane, 4101, Australia
Princess Alexandria Hospital
Woolloongabba, 4102, Australia
Institut Jules Bordet
Brussels, 1000, Belgium
Erasme Hospital
Brussels, 1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Hospital Felicio Rocho
Belo Horizonte, 30110-908, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Hospital das Clinicas da UFPR
Curitiba, 80060-150, Brazil
Hospital de Clinicas da FMUSP - Ribeirao Preto
Ribeirão Preto, 14048-900, Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, 21941-913, Brazil
Hospital Universitario de Santa Maria
Santa Maria, 97105-900, Brazil
Hospital Professor Edmundo Vasconcelos
São Paulo, 04038-905, Brazil
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, L8V 1C3, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hospital Clinico San Borja Arriaran
Santiago, 8320000, Chile
Alexandria University Hospital
Alexandria, 21131, Egypt
National Cancer Institute
Cairo, 11796, Egypt
Nasser Institute
Cairo, 12655, Egypt
Hôpital Edouard Herriot
Lyon, 69437, France
Institut Paoli Calmette - Marseille
Marseille, 13273, France
Hotel Dieu
Nantes, 44093, France
Hôpital Saint-Louis
Paris, 75475, France
Hopital Hautepierre
Strasbourg, 67048, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Charite-Campus Benjamin Franklin
Berlin, 12200, Germany
Universitaet Koeln
Cologne, 50931, Germany
Klinikum Neuperlach
München, 81737, Germany
Medizinische Klinik und Polyklinik II
Würzburg, 97080, Germany
Medanta Medicity Hospital
GÅ«rgaon, Haryan, 122001, India
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
Manipal, Kama, 576104, India
Tata Memorial Hopital, Department of Anesthesia
Mumbai, Mahara, 400012, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Mahara, 411004, India
Global Hospitals & Health City
Chennai, Tamilna, 600100, India
Sterling Hospital
Ahmedabad, 380052, India
Apollo Hospitals
Hyderabad, 500033, India
Sahyadri Specialty Hospital
Pune, 411004, India
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, 91200, Israel
Rabin MC
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, 64239, Israel
American University of Beirut Medical Center
Beirut, 11-0236, Lebanon
Clinique Dr. Rizk
Beirut, 1107-2130, Lebanon
Rafik Hariri University Hospital
Beirut, 5244, Lebanon
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
Mexico City, 14000, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosà City, 78240, Mexico
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02097, Poland
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, 115478, Russia
State Institution "Hematology Research Center" RAMS
Moscow, 125167, Russia
Republican Hospital named after V.A. Baranov
Petrozavodsk, 185019, Russia
St-Petersburg MA Postgraduate Education
Saint Petersburg, 194291, Russia
Private Practice
Lyttleton, Gauteng, 0157, South Africa
Soonchunhyang University Bucheon Hospital
Buchon-si, 420-767, South Korea
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea
Seoul, 137-701, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Maharat Nakhon Ratchasima Hospital
Muang, 30000, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, 50200, Thailand
Ramathibodi Hospital
Ratchathewi, 10400, Thailand
Related Publications (4)
Hamed K, Engelhardt M, Kovanda LL, Huang JJ, Yan J, Aram JA. Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies. Sci Rep. 2023 Apr 25;13(1):6730. doi: 10.1038/s41598-023-31788-1.
PMID: 37185921DERIVEDKovanda 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.
PMID: 27185799DERIVEDThompson 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.
PMID: 27169478DERIVEDMarty 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.
PMID: 26969258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Enrollment in the clinical study was suspended in January 2009 pending further characterization of newly identified impurities. After successful study completion resumption of enrollment started in April 2011 for the 9766-CL-0103/WSA-CS-003 study.
Results Point of Contact
- Title
- Vice President, Medical Head ID/IM/TX
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 12, 2008
Study Start
April 22, 2008
Primary Completion
January 3, 2014
Study Completion
May 5, 2016
Last Updated
December 11, 2024
Results First Posted
January 11, 2016
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/.