Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
NCT ID: NCT00634049
Last Updated: 2024-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
149 participants
INTERVENTIONAL
2008-04-22
2016-05-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
* Participants who are unlikely to survive 30 days
* Participants with a body weight \< 40 kg
* Women who are pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Basilea Pharmaceutica International Ltd
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City Of Hope National Medical Center
Duarte, California, United States
University of California Davis Health System
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University Hospital
Stanford, California, United States
University Of Colorado Health Sciences Center
Aurora, Colorado, United States
Emory Hospital
Atlanta, Georgia, United States
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, United States
Indiana BMT
Beech Grove, Indiana, United States
Infectious Disease of Indiana
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Upstate Infectious Diseases Association LLP
Albany, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, United States
Temple University Health Sciences
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Clinical Research
Seattle, Washington, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, , Argentina
Hospital Nuestra Senora de la Misericordia
Córdoba, , Argentina
Hospital San Roque
Córdoba, , Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, , Argentina
Mater Medical Centre
South Brisbane, , Australia
Princess Alexandria Hospital
Woolloongabba, , Australia
Institut Jules Bordet
Brussels, , Belgium
Erasme Hospital
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Hospital Felicio Rocho
Belo Horizonte, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital das Clinicas da UFPR
Curitiba, , Brazil
Hospital de Clinicas da FMUSP - Ribeirao Preto
Ribeirão Preto, , Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
Hospital Universitario de Santa Maria
Santa Maria, , Brazil
Hospital Professor Edmundo Vasconcelos
São Paulo, , Brazil
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Hospital Clinico San Borja Arriaran
Santiago, , Chile
Alexandria University Hospital
Alexandria, , Egypt
National Cancer Institute
Cairo, , Egypt
Nasser Institute
Cairo, , Egypt
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmette - Marseille
Marseille, , France
Hotel Dieu
Nantes, , France
Hôpital Saint-Louis
Paris, , France
Hopital Hautepierre
Strasbourg, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Aachen
Aachen, , Germany
Charite-Campus Benjamin Franklin
Berlin, , Germany
Universitaet Koeln
Cologne, , Germany
Klinikum Neuperlach
München, , Germany
Medizinische Klinik und Polyklinik II
Würzburg, , Germany
Medanta Medicity Hospital
Gurgaon, Haryan, India
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
Manipal, Kama, India
Tata Memorial Hopital, Department of Anesthesia
Mumbai, Mahara, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Mahara, India
Global Hospitals & Health City
Chennai, Tamilna, India
Sterling Hospital
Ahmedabad, , India
Apollo Hospitals
Hyderabad, , India
Sahyadri Specialty Hospital
Pune, , India
Rambam Health Care Campus
Haifa, , Israel
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, , Israel
Rabin MC
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, , Israel
American University of Beirut Medical Center
Beirut, , Lebanon
Clinique Dr. Rizk
Beirut, , Lebanon
Rafik Hariri University Hospital
Beirut, , Lebanon
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
Mexico City, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, , Russia
State Institution "Hematology Research Center" RAMS
Moscow, , Russia
Republican Hospital named after V.A. Baranov
Petrozavodsk, , Russia
St-Petersburg MA Postgraduate Education
Saint Petersburg, , Russia
Private Practice
Lyttleton, Gauteng, South Africa
Soonchunhyang University Bucheon Hospital
Buchon-si, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Songklanagarind Hospital
Hat Yai, , Thailand
Maharat Nakhon Ratchasima Hospital
Muang, , Thailand
Srinagarind Hospital
Muang, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, , Thailand
Ramathibodi Hospital
Ratchathewi, , Thailand
Countries
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References
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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.
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.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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WSA-CS-003
Identifier Type: OTHER
Identifier Source: secondary_id
2006-005003-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9766-CL-0103
Identifier Type: -
Identifier Source: org_study_id