Study Details

Isavuconazole (BAL8557) in the treatment of candidemia and other invasive candida infections

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT00413218

Astellas Study ID

The unique identification code given by the study sponsor.

9766-CL-0105

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2006-003951-18

Condition

Infections, Fungal Infections

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2007 - Mar 2015

Masking

Double (Participant, Investigator)

Enrollment number

450

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Wonju, Republic of Korea

Tata Memorial Hospital

Mumbai, India

Medical College of Virginia

Richmond, United States

Hospital Alemão Oswaldo Cruz

São Paulo, Brazil, 01323-903

The First Hospital, Jilin University

Changchun, China, 130021

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

SP ZOZ Zespol Szpitali Miejskich w Chorzowie

Chorzow, Poland, 41-500

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico, 44280

Hospital San Roque

Cordoba, Argentina, 5000

Christian Medical College & Hospital

Vellore Tamilnadu, India

University of North Carolina at Chapel Hill

Chapel Hill, United States, 27599

Ospedale Civile S. Bortolo USL 6 di Vicenza

Vicenza, Italy

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Brazil, 30130-100

Hospital Universitario Austral

Pilar, Argentina, 1900

University of Chicago; Division of Infectious Diseases

Chicago, United States, 60637

Bend Memorial Clinic

Bend, United States, 97701

Kasturba Medical College and Hospital

Mangalore, India, 575001

University of Pittsburgh Medical Center - Cancer Centers

Pittsburgh, United States, 15213

Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090

Leeds General Infirmary

Leeds, United Kingdom, LS1 3EX

Universitaetsklinik Leipzig

Leipzig, Germany, 04289

St. Petersburg State Medical Pavlov University

St. Petersburg, Russian Federation, 197089

Hamilton Health Sciences - Henderson Site

Hamilton, Canada, L8V 1C3

Hosp. Vall d´Hebron

Barcelona, Spain, 08035

Haematology and Oncology Clinics of Australasia

South Brisbane, Australia, 4101

University of Alberta Hospital

Edmonton, Canada, T6G 2B7

SBEIHPE “NWSMU n. a. I.I.Mechnikov” of MoH and SD of RF

St. Petersburg, Russian Federation, 194291

General Hospital of Lanzhou Petrol -West

Lanzhou, China, 730060

Universitaetsklinikum Freiburg

Freiburg, Germany

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, Hungary, 4032

Apollo Hospitals Educational & Research Foundation

Chennai, India

Sahyadri Hospital

Pune, India, 411004

Ruijin Hospital, Shanghai Jiatong University School of Medicine

Shanghai, China, 200025

Guro-Gu, Republic of Korea

Universitaet Koeln

Koeln, Germany, 50937

ULB Hôpital Erasme

Bruxelles, Belgium, 1070

Jersey Shore University Medical Center

Neptune, United States, 07753

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma, Argentina, 1426

Crosshouse Hospital

Kilmarnock, United Kingdom, KA2 0BE

Hospital Britanico de Buenos Aires

Capital Federal, Argentina, C1280AEB

University Health Network - Toronto General Hospital

Toronto, Canada, M5G 2N2

Hosp. Clinic i Provincial de Barcelona

Barcelona, Spain, 08036

Loyola University Hospital

Maywood, United States, 60153

Hospital Universitario Clínica San Rafael

Bogota, Colombia

Summa Health System

Akron, United States, 44304

Hospital Sao Lucas - PUCRS

Porto Alegre, Brazil, 90610-000

Mater Adult Hospital

South Brisbane, Australia

Hôpital Edouard Herriot

Lyon cedex 3, France, 69437

Amrita Institute Of Medical Science

Cochin, India, 682041

Hopital Saint-Antoine

Paris Cedex 12, France, 75571

Hadassah Universtiy Hospital - Ein Kerem

Jerusalem, Israel, 91200

Hospital das Clinicas da UFPR

Curitiba, Brazil, 80060-150

Rafik Hariri Uni Hospital

Beirut, Lebanon, 5244

Clínica de Los Virreyes

Ciudad Autonoma Bs As, Argentina, 1426

Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Klinikum St. Georg

Leipzig, Germany, 04129

AUB Medical Center

Beirut, Lebanon, 11-0236

De La Salle Health Sciences Institute- DLSUMC

Cavite City, Philippines

Kochi, India

Songklanagarind Hospital

Hat Yai, Thailand, 90110

University of Alabama at Birmingham

Birmingham, United States, 35294-0006

Chaim Sheba Medical Center

Ramat Gan, Israel, 52621

Ramathibodi Hospital

Ratchathewi, Thailand, 10400

University of California - Los Angeles

Los Angeles, United States, 90095

Hospital Zonal General de Agudos Prof. Dr. Ramón Carrillo

Ciudadela, Argentina, B1702FWM

New York Medical College

Valhalla, United States, 10595

Renji Hospital, Shanghai Jiatong University School of Medicine

Shanghai, China, 20001

Stanford University Hospital

Stanford, United States, 94303

Washington Hospital Center/Medstar Research Institute

Washington, United States, 20010

Hospital Sao Luiz - Analia Franco

São Paulo, Brazil, 03313-001

Hospital ZGA Dr. Carlos Bocalandro

Loma Hermosa, Argentina, 1657

Research Institute for Tropical Medicine

Muntinlupa City, Philippines

Ente Ospedaliero Ospedeli Galliera

Genova, Italy, 16128

Wolfson Medical Center

Holon, Israel, 58100

State Institution "Hematology Research Center" RAMS

Moscow, Russian Federation, 125167

Henry Ford Hospital

Detroit, United States, 48202

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, Malaysia, 56000

Hôpital Hautepierre

Strasbourg, France, 67048

Instituto Nacional de Ciencias Medicas y Nutricion Salvador

Mexico, Mexico, 14000

UMASS Memorial Medical Center

Worcester, United States, 01655

Dipartimento di Malattie Infettive e Tropicali - Ospedale di Circolo - Fondazione Macchi

Varese, Italy, 21100

Philippine General Hospital

Manila, Philippines

People's Hospital, Peking University

Beijing, China, 100044

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy, 25126

Fremantle Hospital

Fremantle, Australia, 6160

Institut Jules Bordet

Brussels, Belgium, 1000

Critical Care Research Royal Alexandra Hospital

Edmonton, Canada, T5H 3V9

CHU Nantes - Hotel Dieu

Nantes Cedex 01, France, 44093

Fundacion Hospital Clinico San Borja Arriaran

Santiago, Chile, 8320000

Indraprastha Apollo Hospitals

DELHI, India, 110076

The First Hospital, Suzhou University

Suzhou, China, 215006

Beijing, China, 88798

Hospital del Salvador

Santiago, Chile

Jackson, United States

Hospital Dr. Hernan Henriquez Aravena

Temuco, Chile, 4780000

Rabin MC

Petah, Israel, 49100

Clinique Rizk Hospital

Beirut, Lebanon, 1107-2130

Hospital de Clinicas da FMUSP - Ribeirao Preto

Ribeirao Preto, Brazil, 14048-900

Remington-Davis Inc.

Columbus, United States, 43215

New York Presbyterian Hospital

New York, United States, 10065

Szegedi Tudomanyegyetem

Szeged, Hungary, 6720

Royal University Hospital

Saskatoon, Canada, S7N 0W8

Perth, Australia

University of California Davis Health System

Sacramento, United States, 95817

West China Hospital of Sichuan University

Chengdu, China, 610041

Hospital Italiano de Buenos Aires

Ciudad Autonoma, Argentina, 1181

Istituto Nazionale per lo studio e la cura dei tumori

Milano, Italy

Cooper University Hospital

Camden, United States, 08103

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Apollo Hospitals

Hyderabad, India, 500033

Hospital General de Agudos Dr. Cosme Argerich

La Boca, Argentina, 1157

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Kasturba Medical College K. M. C. Hospital

Manipal, India, 576104

Clinical Center for Advanced Medical Technologies on b.o. Ci

St. Petersburg, Russian Federation, 197110

Sterling Hospital

Ahmedabad, India, 380052

Marmara University Hospital

Istanbul, Turkey

Hospital Civil de Guadalajara Dr Juan I Menchaca

Guadalajara, Mexico, 44340

Deenanath Mangeshkar Hospital and Research Centre

Pune, India, 411004

Alexandria University Hospital

Alexandria, Egypt, 21131

Huashan Hospital Fudan University

Shanghai, China, 200040

Rush University Medical Center

Chicago, United States, 60612

Universitaetsspital Zuerich

Zurich, Switzerland

Semmelweis University

Budapest, Hungary

Lowcountry Infectious Diseases

Charleston, United States

P. S. G. Institute of Medical Science and Research

Coimbatore, India, 641004

New York Presbyterian Hospital

New York, United States, 10032

National Neuroscience Institute

Singapore, Singapore, 308433

Wayne State University

Detroit, United States, 48201

Institut Paoli Calmette - Marseille

Marseille Cedex 9, France, 13273

Hospital Austral

Pilar, Argentina

Kettering Medical Center

Kettering, United States, 45429

University Of Colorado Health Sciences Center

Aurora, United States, 80045

Singapore General Hospital - Parent

Singapore, Singapore, 169608

University of South Florida College of Medicine

Tampa, United States, 33612

Hospital Pablo Tobon Uribe

Medellin, Colombia

The Lady Davis Carmel Medical Center

Haifa, Israel, 34362

Hospital Universitario de Santa Maria

Santa Maria, Brazil, 97105-900

Instituto Nacional de Cancerologia

Mexico, Mexico, 14080

Maharat Nakhon Ratchasima Hospital

Muang, Thailand, 30000

Khon Kaen, Thailand

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosi, Mexico, 78240

M.P. Shah Cancer Hospital Gujarat Cancer and Research Institute Civil hospital

Ahmedabad, India, 380016

Hôpital de Brabois Adultes

Vandoeuvre les Nancy, France, 54511

Somero Research Corporation

Palm Desert, United States, 92211

Hospital Dr. Sotero del Rio

Puente Alto Santiago, Chile

University of Miami - Miller School of Medicine

Miami, United States, 33136

Centro de Invest Oncologicas Clinica San Diego-CIOSAD SA

Bogota, Colombia

Hopital Paul Brousse

Villejuif, France

Nizam's Institute of Medical Sciences

Hyderabad, India, 500082

Upstate Infectious Diseases Association LLP

Albany, United States, 12208

Ayr Hospital

Ayr, United Kingdom, KA6 6DX

Waikato Urology Research Ltd

Hamilton, New Zealand

California Pacific Medical Center

San Francisco, United States, 94110

Blokhin Research Oncology Centre

Moscow, Russian Federation, 115478

William Beaumont Hospital

Royal Oak, United States, 48073

Jehangir Clinical Development Centre Pvt. Ltd.

Pune, India, 411001

Chiangmai, Thailand

Temple University School of Medicine

Philadelphia, United States, 19104

Hospital Heliópolis

São Paulo, Brazil, 04230-000

Fundación Valle de Lilli

Cali, Colombia

Sir Gangaram Hospital

New Delhi, India, 110060

Grootte Schuur Hospital

Cape Town, South Africa, 7925

University of Maryland School of Medicine

Baltimore, United States, 21201

Hospital Israelita Albert Einstein

Sao Paulo, Brazil, 05651-901

Hospital de Clinicas de Porto Alegre -UFRGS

Porto Alegre, Brazil, 90035-003

Infectious Disease of Indiana

Indianapolis, United States, 46280

Hospital Nossa Senhora das Gracas

Curitiba, Brazil, 80810-040

St. John's Hospital

Springfield, United States, 62702

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Chile

Buenos Aires, Argentina, C1181ACH

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Mexico, 64460

Hospital Universitario San Vicente de Paul

Medellin, Colombia

Christiana Care Research Institute

Newark, United States, 19713

Petz Aladar Megyei Oktato Korhaz

Györ, Hungary, 9024

RSP Infectious Disease

West Reading, United States, 19611

Springfield Clinic LLP

Springfield, United States, 62701

Universitaetsklinikum Leipzig

Luebeck, Germany

Hospital do Servidor Publico Estadual de Sao Pablo

Ibirapuera, Brazil, 04029-000

Boanerges Clinical Research

Bloemfontein, South Africa, 9301

Hospital Ampang

Ampang, Malaysia, 68000

Hospital de Baso de Sao Jose do Rio Preto

Sao Jose do Rio Preto, Brazil, 15090-000

Sapir Medical Center, Meir Hospital

Kfar-Saba, Israel, 44281

Hacettepe University Hospital

Ankara, Turkey

Medanta Medicity Hospital

Gurgaon, India, 12201

Incheon, Republic of Korea

Ain Shams University Hospital

Cairo, Egypt, 11566

University of California at San Francisco

San Francisco, United States, 94143

UCT Medical School

Cape Town, South Africa

Buenos Aires, Argentina, C1426ANZ

Instituto Especializado del Caribe - INESCA

Barranquilla, Colombia

Lehigh Valley Hospital

Allentown, United States, 18103

Duke University

Durham, United States, 27710

Universitaetsklinikum Regensburg

Regensburg, Germany, 93042

Wake Forest University Health Sciences

Winston-Salem, United States, 27157

Hospital del Mar

Barcelona, Spain, 08003

Wuhan Union Hospital

Wuhan, China, 430022

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, 3000

Srinagarind Hospital

Muang, Thailand, 40002

Grupo Jasovich

Ciudad Autonoma, Argentina, 1419

Hospital das Clinicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma

Bologna, Italy, 40138

Los Angeles Biomedical Research Institute at Harbor-UCLA Med

Torrance, United States, 90509

Siriraj Hospital

Bangkoknoi, Thailand, 10700

University of Minnesota

Minneapolis, United States, 55455

AMRI Hospital

Kolkata, India, 700098

Santiago Quilicura, Chile

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

Hospital San Juan de Dios

Santiago, Chile

Buenos Aires, Argentina, C1039AAO

Max Super Speciality Hospital

New Delhi, India, 110017

Bhagwan Mahaveer Psychiatry & De-addiction Centre

Jaipur, India, 303706

Universidade Federal de Sao Paulo - UNIFESP

São Paulo, Brazil, 04020-002

Nasser Institute

Cairo, Egypt, 12655

Regional Infection Diseases Infusion Center Inc.

Lima, United States, 45801

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Princess Alexandra Hospital

Woolloongabba, Australia, 4102

CHU de Dijon-Hopital du Bocage

Dijon, France, 21079

Azienda Ospedaliero Universitaria San Martino

Genova, Italy, 16132

The Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

Hôpitaux Universitaires de Genève - HUG

Geneva, Switzerland

Hospital Felicio Rocho

Belo Horizonte, Brazil, 30110-908

Westmead Hospital

Westmead, Australia

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China, 310009

University of Pennsylvania Health System

Philadelphia, United States, 19104

Noida, India

University of Wisconsin School of Medicine and Public Health

Madison, United States, 53805-2281

Rajavithi Hospital

Bangkok, Thailand, 10400

Songkla, Thailand

Metro Centre for Respiratory Diseases

Noida, India, 201301

Hospital Professor Edmundo Vasconcelos

São Paulo, Brazil, 04038-905

Nakhon Ratchasima, Thailand

Indiana BMT

Beech Grove, United States, 46107

Guadalajara, Mexico, 44140

Sanatorio Allende

Cordoba, Argentina

Houston, United States

Tufts Medical Center, Inc.

Boston, United States, 02109

S.I. Russian Oncological Research Center n.a. N.N. Blokhin

Moscow, Russian Federation, 115478

St. John's Hospital and Medical Center

Detroit, United States, 48236

Unitas Hospital

Lyttelton Centurion, South Africa, 0157

Clinica Las Condes

Santiago, Chile

Hospital Dr. Jose Maria Cullen

Santa Fe, Argentina, S3000EOZ

Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio

Santiago, Chile, 8320000

Buenos Aires, Argentina, A1155ADP

Rambam Health Care Campus

Haifa, Israel, 31096

Queen's University

Kingston, Canada, K7L 3N6

Ochsner Clinic Foundation

New Orleans, United States, 70121

Global Hospitals & Health City

Chennai, India, 600100

Institute of Hematology and Hospital of Blood Disease

Tianjin, China, 300020

Sourasky MC Ichilov Hospital Tel Aviv

Tel Aviv, Israel, 64239

The 1st Affiliated Hospital of Guangxi Medical University

Nanning, China, 530021

Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

Verona, Italy, 37134

Samodzielny Publiczny Centralny Szpital Kliniczny

Warszawa, Poland, 02-097

Kansas City VA Medical Center

Kansas City, United States, 64128

Hospital General de Agudos Dr. Carlos G. Durand

Capital Federal, Argentina, C1405DCS

Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, Brazil, 21941-913

Maharaj Nakorn Chiang Mai Hospital

Muang, Thailand, 50200

Hôpital Maisonneuve - Rosemont

Montreal, Canada, H1T 2M4

Hospital São Vicente de Paulo

Passo Fundo, Brazil, 99010-080

Seoul, Republic of Korea

San Francisco, United States, 94115

Buenos Aires, Argentina, 1702

Charite Campus Mitte

Berlin, Germany, 10117

Emory Hospital

Atlanta, United States, 30322

CEMIC

Ciudad Autonoma, Argentina, 1431

The First Affiliated Hospital, Med. School, Zhejiang Uni.

Hangzhou, China, 310003

Temple University Health Sciences

Philadelphia, United States, 19140

National Cancer Institute

Cairo, Egypt, 11796

AZ Sint-Jan

Brugge, Belgium, 8000

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil, 30150-221

Klinikum Neuperlach Schwabing

Muenchen, Germany, 81737

Renji Hospital Shanghai Jiatong University School of Medicine

Shanghai, China, 20043

Idaho Falls Infectious Diseases PLLC

Idaho Falls, United States, 83404

Asklepiosklinik Altona

Hamburg, Germany

Republican Hospital named after V.A. Baranov

Petrozavodsk, Russian Federation, 185019

Jackson, United States

Sanatorio Julio Mendez

Buenos Aires, Argentina

Johns Hopkins University

Baltimore, United States, 21205

3rd Hospital, Beijing University

Beijing, China, 100089

Mercury Street Medical Group

Butte, United States, 59701

Hospital das Clinicas da Universidade Federal de Minas Gerai

Belo Horizonte, Brazil, 30130-100

Hospital Base de Valdivia

Valdivia, Chile

Hospital General de Mexico

Mexico D.F., Mexico, 06726

Sanatorio de la Trinidad Mitre

Ciudad Autonoma, Argentina, 1039

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, Brazil, 01246-000

H del Mar

Cadiz, Spain

Auckland City Hospital

Auckland, New Zealand

Hospital Nuestra Señora de la Misericordia

Cordoba, Argentina, 5000

Brigham & Womens Hospital

Boston, United States, 02115

VA Western New York Healthcare System

Buffalo, United States, 14215

Ha Emek Medical Center

Afula, Israel, 18101

Universitair Medisch Centrum St. Radboud

Nijmegen, Netherlands