Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi (VITAL)
Aspergillosis, Invasive Fungal Infections
About this trial
This is an interventional treatment trial for Aspergillosis focused on measuring invasive fungal infections caused by rare molds, rare yeasts, BAL8557, Isavuconazole, Aspergillosis, or by dimorphic fungi, ASP9766
Eligibility Criteria
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.
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
Sites / Locations
- University of Alabama at Birmingham
- City Of Hope National Medical Center
- University of California Davis Health System
- California Pacific Medical Center
- University of California at San Francisco
- Stanford University Hospital
- University Of Colorado Health Sciences Center
- Emory Hospital
- University of Chicago, Division of Infectious Diseases
- Indiana BMT
- Infectious Disease of Indiana
- Ochsner Clinic Foundation
- Brigham & Womens Hospital
- UMASS Memorial Medical Center
- Wayne State University School of Medicine
- Henry Ford Hospital
- University of Minnesota
- Upstate Infectious Diseases Association LLP
- Cleveland Clinic
- Regional Infection Diseases Infusion Center Inc.
- Temple University Health Sciences
- University of Pittsburgh Medical Center Health System
- University of Texas MD Anderson Cancer Center
- Fred Hutchinson Cancer Research Center, Clinical Research
- Hospital Italiano de Buenos Aires
- Instituto Medico Especializado Alexander Fleming
- Hospital Nuestra Senora de la Misericordia
- Hospital San Roque
- Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
- Mater Medical Centre
- Princess Alexandria Hospital
- Institut Jules Bordet
- Erasme Hospital
- Universitair Ziekenhuis Gent
- Universitaire Ziekenhuizen Leuven
- Hospital Felicio Rocho
- Santa Casa de Misericordia de Belo Horizonte
- Hospital das Clinicas da UFPR
- Hospital de Clinicas da FMUSP - Ribeirao Preto
- Hospital Universitario Clementino Fraga Filho
- Hospital Universitario de Santa Maria
- Hospital Professor Edmundo Vasconcelos
- Hamilton Health Sciences - Henderson Site
- The Ottawa Hospital - General Campus
- Hôpital Maisonneuve - Rosemont
- Hôpital Maisonneuve - Rosemont
- Hospital Clinico San Borja Arriaran
- Alexandria University Hospital
- National Cancer Institute
- Nasser Institute
- Hôpital Edouard Herriot
- Institut Paoli Calmette - Marseille
- Hotel Dieu
- Hôpital Saint-Louis
- Hopital Hautepierre
- Hôpital de Brabois Adultes
- Universitaetsklinikum Aachen
- Charite-Campus Benjamin Franklin
- Universitaet Koeln
- Klinikum Neuperlach
- Medizinische Klinik und Polyklinik II
- Medanta Medicity Hospital
- Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
- Tata Memorial Hopital, Department of Anesthesia
- Deenanath Mangeshkar Hospital & Research Centre
- Global Hospitals & Health City
- Sterling Hospital
- Apollo Hospitals
- Sahyadri Specialty Hospital
- Rambam Health Care Campus
- Hadassah Universtiy Hospital - Ein Kerem
- Rabin MC
- Chaim Sheba Medical Center
- Sourasky MC Ichilov Hospital Tel Aviv
- Soonchunhyang University Bucheon Hospital
- Gachon University Gil Hospital
- Samsung Medical Center
- The Catholic University of Korea
- Asan Medical Center
- American University of Beirut Medical Center
- Clinique Dr. Rizk
- Rafik Hariri University Hospital
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- Hospital Central Dr Ignacio Morones Prieto
- Samodzielny Publiczny Centralny Szpital Kliniczny
- S.I. Russian Oncological Research Center n.a. N.N. Blokhin
- State Institution "Hematology Research Center" RAMS
- Republican Hospital named after V.A. Baranov
- St-Petersburg MA Postgraduate Education
- Private Practice
- Songklanagarind Hospital
- Maharat Nakhon Ratchasima Hospital
- Srinagarind Hospital
- Maharaj Nakorn Chiang Mai Hospital
- Ramathibodi Hospital
Arms of the Study
Arm 1
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