Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Candidiasis, Invasive, Candidemia, Mycoses
About this trial
This is an interventional treatment trial for Candidiasis, Invasive focused on measuring Invasive Candida infections, BAL8557, ASP9766, Isavuconazole, Candidemia, Candidemia and other invasive candida infections, Phase III study
Eligibility Criteria
Inclusion Criteria:
- Patients with candidemia or with an invasive Candida infection
- Presence of fever, hypothermia or other appropriate local sign of infection
- Female patients must be non-lactating and at no risk of pregnancy
Exclusion Criteria:
- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens
- Patients with candidemia who failed a previous antifungal therapy for the same infection
- Patients previously enrolled in a phase III study with isavuconazole
- Patients with a body weight <40kg
Sites / Locations
- University of Alabama at Birmingham
- Somero Research Corporation
- University of California Davis Health System
- University of California at San Francisco
- Idaho Falls Infectious Diseases PLLC
- Loyola University Hospital
- Springfield Clinic LLP
- Infectious Disease of Indiana
- Ochsner Clinic Foundation
- University of Maryland School of Medicine
- UMASS Memorial Medical Center
- Henry Ford Hospital
- Mercury Street Medical Group
- Jersey Shore University Medical Center
- New York Presbyterian Hospital
- Wake Forest University Health Sciences
- Regional Infection Diseases Infusion Center Inc.
- Temple University Health Sciences
- Hospital Britanico de Buenos Aires
- Hospital General de Agudos Dr. Carlos G. Durand
- Hospital Italiano de Buenos Aires
- Instituto Medico Especializado Alexander Fleming
- Hospital General de Agudos Dr. Cosme Argerich
- Fremantle Hospital
- Mater Adult Hospital
- Westmead Hospital
- Princess Alexandra Hospital
- Institut Jules Bordet
- Universitair Ziekenhuis Brussel
- ULB Hôpital Erasme
- Universitair Ziekenhuis Gent
- Universitaire Ziekenhuizen Leuven
- Hospital Felicio Rocho
- Hospital das Clinicas da Universidade Federal de Minas Gerai
- Santa Casa de Misericordia de Belo Horizonte
- Hospital das Clinicas da UFPR
- Hospital Nossa Senhora das Gracas
- Hospital Sao Lucas - PUCRS
- Irmandade da Santa Casa de Misericordia de Porto Alegre
- Hospital Universitario Clementino Fraga Filho
- Hospital Universitario de Santa Maria
- Universidade Federal de Sao Paulo - UNIFESP
- University of Alberta Hospital
- Hamilton Health Sciences - Henderson Site
- Queen's University
- The Ottawa Hospital - General Campus
- University Health Network - Toronto General Hospital
- Hôpital Maisonneuve - Rosemont
- Hospital Dr. Sotero del Rio
- Hospital del Salvador
- Hospital Dr. Hernan Henriquez Aravena
- West China Hospital of Sichuan University
- Huashan Hospital Fudan University
- Hôpital Hautepierre
- Hôpital de Brabois Adultes
- Charite Campus Mitte
- Universitaetsklinikum Freiburg
- Universitaet Koeln
- Klinikum St. Georg
- Universitaetsklinik Leipzig
- Universitaetsklinikum Leipzig
- Universitaetsklinikum Wuerzburg
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
- Petz Aladar Megyei Oktato Korhaz
- Max Super Speciality Hospital
- Metro Centre for Respiratory Diseases
- Kasturba Medical College and Hospital
- Kasturba Medical College K. M. C. Hospital
- Amrita Institute Of Medical Science
- Deenanath Mangeshkar Hospital and Research Centre
- Apollo Hospitals Educational & Research Foundation
- Nizam's Institute of Medical Sciences
- AMRI Hospital
- Christian Medical College & Hospital
- Ha Emek Medical Center
- Rambam Health Care Campus
- Wolfson Medical Center
- Hadassah Universtiy Hospital - Ein Kerem
- Sapir Medical Center, Meir Hospital
- Rabin MC
- Chaim Sheba Medical Center
- Sourasky MC Ichilov Hospital Tel Aviv
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma
- Azienda Ospedaliera Spedali Civili di Brescia
- Ente Ospedaliero Ospedeli Galliera
- Azienda Ospedaliero Universitaria San Martino
- Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
- AUB Medical Center
- Rafik Hariri Uni Hospital
- Hospital Ampang
- Pusat Perubatan Universiti Kebangsaan Malaysia
- Hospital Civil de Guadalajara Fray Antonio Alcalde
- Hospital Civil de Guadalajara Dr Juan I Menchaca
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- Auckland City Hospital
- Waikato Urology Research Ltd
- De La Salle Health Sciences Institute- DLSUMC
- Philippine General Hospital
- S.I. Russian Oncological Research Center n.a. N.N. Blokhin
- State Institution "Hematology Research Center" RAMS
- Singapore General Hospital - Parent
- National Neuroscience Institute
- Unitas Hospital
- Hospital del Mar
- Hôpitaux Universitaires de Genève - HUG
- Universitaetsspital Zuerich
- Siriraj Hospital
- Songklanagarind Hospital
- Maharat Nakhon Ratchasima Hospital
- Srinagarind Hospital
- Maharaj Nakorn Chiang Mai Hospital
- Ramathibodi Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Isavuconazole (ISA)
Caspofungin (CAS)/Voriconazole
Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.