Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Condition(s) targeted: Mycoses; Candidiasis, Invasive; Candidemia

Intervention: Isavuconazole (Drug); Caspofungin (Drug); Voriconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Global Development

The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Official title: A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Overall response at end of intravenous (IV) therapy

Secondary outcome:

Overall response

Mycological response as determined by the independent DRC

Clinical response as determined by the independent DRC

Mycological response as determined by the investigator

Clinical response as determined by the investigator

Time to first confirmed negative culture

All-cause mortality

Detailed description: Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral Isavuconazole. Patients are randomized to Isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hospital Britanico de Buenos Aires, Capital Federal C1280AEB, Argentina

Hospital General de Agudos Dr. Carlos G. Durand, Capital Federal C1405DCS, Argentina

Hospital Italiano de Buenos Aires, Ciudad Autonoma 1181, Argentina

Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma 1426, Argentina

Hospital General de Agudos Dr. Cosme Argerich, La Boca 1157, Argentina

Fremantle Hospital, Fremantle 6160, Australia

Mater Adult Hospital, South Brisbane, Australia

Westmead Hospital, Westmead, Australia

Princess Alexandra Hospital, Woolloongabba 4102, Australia

Institut Jules Bordet, Brussels 1000, Belgium

Universitair Ziekenhuis Brussel, Brussels 1090, Belgium

ULB Hôpital Erasme, Bruxelles 1070, Belgium

Universitair Ziekenhuis Gent, Gent 9000, Belgium

Universitaire Ziekenhuizen Leuven, Leuven 3000, Belgium

Hospital das Clinicas da Universidade Federal de Minas Gerai, Belo Horizonte 30130-100, Brazil

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 Nossa Senhora das Gracas, Curitiba 80810-040, Brazil

Hospital Sao Lucas - PUCRS, Porto Alegre 90610-000, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil

Hospital Universitario Clementino Fraga Filho, Rio de Janeiro 21941-913, Brazil

Hospital Universitario de Santa Maria, Santa Maria 97105-900, Brazil

Universidade Federal de Sao Paulo - UNIFESP, São Paulo 04020-002, Brazil

Hospital Dr. Sotero del Rio, Puente Alto Santiago, Chile

Hospital del Salvador, Santiago, Chile

Hospital Dr. Hernan Henriquez Aravena, Temuco 4780000, Chile

West China Hospital of Sichuan University, Chengdu 610041, China

Huashan Hospital Fudan University, Shanghai 200040, China

Hôpital Hautepierre, Strasbourg 67048, France

Hôpital de Brabois Adultes, Vandoeuvre les Nancy 54511, France

Charite Campus Mitte, Berlin 10117, Germany

Universitaetsklinikum Freiburg, Freiburg, Germany

Universitaet Koeln, Koeln 50937, Germany

Klinikum St. Georg, Leipzig 04129, Germany

Universitaetsklinik Leipzig, Leipzig 04289, Germany

Universitaetsklinikum Leipzig, Luebeck, Germany

Universitaetsklinikum Wuerzburg, Wuerzburg 97080, Germany

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen 4032, Hungary

Petz Aladar Megyei Oktato Korhaz, Györ 9024, Hungary

Apollo Hospitals Educational & Research Foundation, Chennai, India

Nizam's Institute of Medical Sciences, Hyderabad 500082, India

AMRI Hospital, Kolkata 700098, India

Christian Medical College & Hospital, Vellore Tamilnadu, India

Ha Emek Medical Center, Afula 18101, Israel

Rambam Health Care Campus, Haifa 31096, Israel

Wolfson Medical Center, Holon 58100, Israel

Hadassah Universtiy Hospital - Ein Kerem, Jerusalem 91200, Israel

Sapir Medical Center, Meir Hospital, Kfar-Saba 44281, Israel

Rabin MC, Petah 49100, Israel

Chaim Sheba Medical Center, Ramat Gan 52621, Israel

Sourasky MC Ichilov Hospital Tel Aviv, Tel Aviv 64239, Israel

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma, Bologna 40138, Italy

Azienda Ospedaliera Spedali Civili di Brescia, Brescia 25126, Italy

Azienda Ospedaliero Universitaria San Martino, Genova 16132, Italy

Ente Ospedaliero Ospedeli Galliera, Genova 16128, Italy

Azienda Ospedaliera di Verona-Ospedale Civile Maggiore, Verona 37134, Italy

AUB Medical Center, Beirut 11-0236, Lebanon

Rafik Hariri Uni Hospital, Beirut 5244, Lebanon

Hospital Ampang, Ampang 68000, Malaysia

Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia

Hospital Civil de Guadalajara Dr Juan I Menchaca, Guadalajara 44340, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara 44280, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador, Mexico 14000, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey 64460, Mexico

Auckland City Hospital, Auckland, New Zealand

Waikato Urology Research Ltd, Hamilton, New Zealand

De La Salle Health Sciences Institute- DLSUMC, Cavite City, Philippines

Philippine General Hospital, Manila, Philippines

S.I. Russian Oncological Research Center n.a. N.N. Blokhin, Moscow 115478, Russian Federation

State Institution "Hematology Research Center" RAMS, Moscow 125167, Russian Federation

National Neuroscience Institute, Singapore 308433, Singapore

Singapore General Hospital - Parent, Singapore 169608, Singapore

Unitas Hospital, Lyttelton Centurion 0157, South Africa

Hospital del Mar, Barcelona 08003, Spain

Hôpitaux Universitaires de Genève - HUG, Geneva, Switzerland

Universitaetsspital Zuerich, Zurich, Switzerland

Siriraj Hospital, Bangkoknoi 10700, Thailand

Songklanagarind Hospital, Hat Yai 90110, Thailand

Maharaj Nakorn Chiang Mai Hospital, Muang 50200, Thailand

Maharat Nakhon Ratchasima Hospital, Muang 30000, Thailand

Srinagarind Hospital, Muang 40002, Thailand

Ramathibodi Hospital, Ratchathewi 10400, Thailand

University of Alabama at Birmingham, Birmingham, Alabama 35294-0006, United States

University of Alberta Hospital, Edmonton, Alberta T6G 2B7, Canada

Somero Research Corporation, Palm Desert, California 92211, United States

University of California Davis Health System, Sacramento, California 95817, United States

University of California at San Francisco, San Francisco, California 94143, United States

Max Super Speciality Hospital, New Delhi, Delhi 110017, India

Metro Centre for Respiratory Diseases, Noida, Delhi 201301, India

Idaho Falls Infectious Diseases PLLC, Idaho Falls, Idaho 83404, United States

Loyola University Hospital, Maywood, Illinois 60153, United States

Springfield Clinic LLP, Springfield, Illinois 62701, United States

Infectious Disease of Indiana, Indianapolis, Indiana 46280, United States

Kasturba Medical College and Hospital, Mangalore, Karna 575001, India

Kasturba Medical College K. M. C. Hospital, Manipal, Karna 576104, India

Amrita Institute Of Medical Science, Cochin, Kerala 682041, India

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Deenanath Mangeshkar Hospital and Research Centre, Pune, Mahara 411004, India

University of Maryland School of Medicine, Baltimore, Maryland 21201, United States

UMASS Memorial Medical Center, Worcester, Massachusetts 01655, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Mercury Street Medical Group, Butte, Montana 59701, United States

Jersey Shore University Medical Center, Neptune, New Jersey 07753, United States

New York Presbyterian Hospital, New York, New York 10065, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Regional Infection Diseases Infusion Center Inc., Lima, Ohio 45801, United States

Hamilton Health Sciences - Henderson Site, Hamilton, Ontario L8V 1C3, Canada

Queen's University, Kingston, Ontario K7L 3N6, Canada

The Ottawa Hospital - General Campus, Ottawa, Ontario K1H 8L6, Canada

University Health Network - Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada

Temple University Health Sciences, Philadelphia, Pennsylvania 19140, United States

Hôpital Maisonneuve - Rosemont, Montreal, Quebec H1T 2M4, Canada

Starting date: December 2006
Last updated: March 30, 2015