Study Details

Isavuconazole (BAL8557) for primary treatment of invasive aspergillosis

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). ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

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



Infections, Yeast Fungal Infections


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


18 years - N/A


Female & Male




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.


Trial Dates

Mar 2007 - Mar 2013


Double (Participant, Investigator)

Enrollment number


A phase III, double blind, randomized study to evaluate safety and efficacy of BAL8557 versus voriconazole for primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi.

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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University Of Colorado Health Sciences Center

Aurora, United States, 80045

West China Hospital of Sichuan University

Chengdu, China, 610041

University of Chicago, Division of Infectious Diseases

Chicago, United States, 60637

Christchurch, New Zealand, 8010

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, Brazil, 01246-000

Huashan Hospital, Insitute of Antibiotics

Shanghai, China, 200040

Medellin, Colombia

Nijmegen, Netherlands, 6525

Fremantle, Australia, 6160

Freiburg, Germany, 79106

São Paulo, Brazil, 04020-002

Kuala Lumpur, Malaysia, 59100

Chiang Mai, Thailand, 50200

Alexandria University Hospital

Alexandria, Egypt, 21131

Buenos Aires, Argentina

Rabin MC

Petah Tikva, Israel, 49100

Nakhon Ratchasima, Thailand, 30000

Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi

Firenze, Italy, 50134

Paris, France, 75015

The Catholic University of Korea, St. Mary's Hospital

Seoul, Republic of Korea, 137-701

Kuala Lumpur, Malaysia, 68000

Hospital de Clinicas da FMUSP - Ribeirao Preto

Ribeirão Preto, Brazil, 14048-900

Rambam Health Care Campus

Haifa, Israel, 31096

Dallas, United States, 75246

Hôpital Saint-Louis Charite

Paris Cedex 10, France, 75475

St. Petersburg, Russian Federation, 197110

Hamilton, New Zealand, 3204

Mumbai, India, 400012

Hospital Italiano de La Plata

La Plata, Argentina, 1900

Jeddah, Saudi Arabia

St-Petersburg MA Postgraduate Education

St. Petersburg, Russian Federation, 194291

Samsung Medical Center

Seoul, Republic of Korea, 135-710

Ahmedabad, India, 380016

Wuhan Union Hospital

Wuhan, China, 430022

The Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

Bend Memorial Clinic

Bend, United States, 97701

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil, 30150-221

No.6 Renmin Hosp. of Shanghai City

Shanghai, China, 200233

State Institution "Hematology Research Center" RAMS

Moscow, Russian Federation, 125167

Fundacion Arriaran Hospital Clinico San Borja Arriaran

Santiago, Chile, 8320000

Woolloongabba, Australia, 4102

Kasturba Medical College and Hospital

Mangalore, India, 575001

Sanatorio de la Trinidad Mitre

Ciudad Autonoma Bs As, Argentina, 1039

Muntinlupa City, Philippines, 1781

University of California at San Francisco

San Francisco, United States, 94143

Soonchunhyang University Bucheon Hospital

Buchon-si, Republic of Korea, 420-767

University of Nebraska Medical Center

Omaha, United States, 68198

Cali, Colombia

Regional Infection Diseases Infusion Center Inc.

Lima, United States, 45801

Beijing, China, 100730

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Mexico, 64040

Institut Paoli Calmette - Marseille

Marseille Cedex 9, France, 13273

Minneapolis, United States, 55422

Indiana BMT

Springfield, United States, 62703

St. Petersburg, Russian Federation, 197089

Fred Hutchinson Cancer Research Center, Clinical Research

Seattle, United States, 98109

Tampa, United States, 33606

Hospital Universitario de Santa Maria

Santa Maria, Brazil, 97105-900

Villejuif, France, 94800

Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Milano, Italy, 20100

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Leningrad Regional Hospital

St. Petersburg, Russian Federation, 194291

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma, Argentina, 1426

Hôpital Edouard Herriot

Lyon cedex 3, France, 69437

Kangdong Sacred Heart Hospital

Seoul, Republic of Korea, 134-701

People's Hospital, Peiking University

Beijing, China, 100044

Ramathibodi Hospital

Ratchathewi, Thailand, 10400

Maharaj Nakorn Chiang Mai Hospital

Muang, Thailand, 50200

Riyadh, Saudi Arabia, 11159

Noida, India, 201301

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milano, Italy, 20162

Buenos Aires, Argentina, 1702

Chaim Sheba Medical Center

Ramat-Gan, Israel, 52621

University of Maryland School of Medicine

Baltimore, United States, 21201

Hopital Saint-Antoine

Paris Cedex 12, France, 75571

SP ZOZ Zespol Szpitali Miejskich w Chorzowie

Chorzow, Poland, 41-500

The 1st Hospital, Jilin University

Changchun, China, 130021

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31501

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Budapest, Hungary, 1094

Hospital de Baso de Sao Jose do Rio Preto

Sao Jose do Rio Preto, Brazil, 15090-000

Nasser Institute

Cairo, Egypt, 12655

Hospital General de Agudos Dr. Cosme Argerich

La Boca, Argentina, 1157

Hospital das Clinicas da Universidade Federal de Minas Gerai

Belo Horizonte, Brazil, 30130-100

Hospital Nuestra Senora de la Misericordia

Cordoba, Argentina, 5000

Cordoba, Argentina, X5000JHQ

St. Francis Hospital and Health Centers

Beech Grove, United States, 46107

Xian, China, 710038

Columbia, United States, 65212

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

Moscow, Russian Federation, 115478

Madrid, Spain, 28046

Universitaet Koeln

Köln, Germany, 50937

Perth, Australia, 6000

Klinikum Schwabing

Muenchen, Germany, 81737

Hôpital de brabois adultes

Vandoeuvre les Nancy, France, 54511

Cape Town, South Africa, 7925

Halle, Germany, 06120

AUB Medical Center

Beirut, Lebanon, 11 0236

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico, 44140

Kolkata, India, 700029

Sourasky MC Ichilov Hospital Tel Aviv

Tel Aviv, Israel, 64239

Temple University Health Sciences

Philadelphia, United States, 19140

Gdansk, Poland, 80952

Edmonton, Canada, T6G 2E1

University of Alabama

Birmingham, United States, 35294-0006

Hôpital Maisonneuve - Rosemont

Montreal, Canada, H1T 2M4

Cheras, Kuala Lumpur, Malaysia, 56000

Curitiba, Brazil, 80810-040

Barranquilla, Colombia

Singapore General Hospital- Parent

Singapore, Singapore, 169608

Srinagarind Hospital

Muang, Thailand, 40002

University of Minnesota

Minneapolis, United States, 55455

Al Ahsa, Saudi Arabia

Gachon University Gil Hospital

Incheon, Republic of Korea, 405-760

CHU de Nantes - Hôpital Hôtel Dieu

Nantes Cedex, France, 44035

Worcester, United States, 01655

Santiago, Chile

Oklahoma City, United States, 73104


Brugge, Belgium, 8000

Hyderabad, India, 500082

Samodzielny Publiczny Centralny Szpital Kliniczny

Warszawa, Poland, 02-097

Medanta Medicity Hospital

Gurgaon, India, 122001

The First Hospital, Suzhou University

Suzhou, China, 215006

Tata Memorial Hopital, Department of Anesthesia

Mumbai, India, 400012

Upstate Infectious Diseases Association LLP

Albany, United States, 12208

Toronto, Canada, M5G 2C4

Pilar, Argentina, B1164INZ

Instituto Nacional de Ciencias Medicas y Nutricion Salvador

Mexico, Mexico, 14000

Asan Medical Center

Seoul, Republic of Korea, 138-736

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China, 200032

Barcelona, Spain, 08036

Buenos Aires, Argentina, C1039AAO

New York, United States, 10021

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Valencia, Spain, 46009

Buenos Aires, Argentina, 1426

Clinique Rizk Hospital

Beirut, Lebanon, 1107-2130

Geneva, Switzerland, 1211

Tufts Medical Center, Inc.

Boston, United States, 02109

Felicio Rocho

Belo Horizonte, Brazil, 30110-908

Lima, Peru, 13

Emory Hospital

Atlanta, United States, 30322

New Orleans, United States, 70121

Brigham & Womens Hospital

Boston, United States, 02115

The 1st Affiliated Hospital of Guangxi Medical University

Nanning, China, 530021

Berlin, Germany, 10117

Henry Ford Hospital

Detroit, United States, 48202

Porto Alegre, Brazil, 90610-000

Guangzhou, China, 510515

Capital Federal, Argentina, C1405DCS

Dr H J van Rensburg

Lyttelton Centurion, South Africa, 157

Hospital Italiano de Buenos Aires

Ciudad Autonoma, Argentina, 1181

Hospital Professor Edmundo Vasconcelos

São Paulo, Brazil, 04038-905

Buenos Aires, Argentina, C1157ADP

Infectious Disease of Indiana

Indianapolis, United States, 46280

Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, Brazil, 21941-913

Mater Medical Centre

South Brisbane, Australia, 4101

Oregon Health & Science University

Portland, United States, 97239

Philadelphia, United States, 19140-5189

Global Hospitals & Health City

Chennai, India, 600100

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Medizinische klinik und Polyklinik II

Würzburg, Germany, 97080

Charité Universitaetsmedizin Berlin- Campus Charité Mitte

Berlin, Germany, 12200

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

Hangzhou, China, 310003

Christchurch, New Zealand, 8001

Palmerston North, New Zealand, 4442

Vicenza, Italy, 36100

Apollo Hospitals

Hyderabad, India, 500033

Budapest, Hungary, 1082

Khon Kaen, Thailand, 40002

National Cancer Institute

Cairo, Egypt, 11796

Queen's University

Kingston, Canada, K7L 3N6

Auckland, New Zealand

Akron, United States, 44304

New York Medical College

Valhalla, United States, 10595

Chang Hai Hospital

Shanghai, China, 200433

Hamilton Health Sciences - Henderson Site

Hamilton, Canada, L8V 1C3

Valdivia, Chile, 5090000

Palmerston North, New Zealand, 4442

Trois-Rivieres, Canada, G8Z 3R9

Springfield Clinic LLP

Springfield, United States, 62703

Ankara, Turkey, 06100

Singapore, Singapore, 169608

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China, 310009

Universitaetsklinik Leipzig

Leipzig, Germany, 04289

Auckland, New Zealand, 1010

Hôpital Hautepierre

Strasbourg, France, 67098

Grupo Jasovich

Ciudad Autonoma Bs As, Argentina, C1035AAP

National Neuroscience Institute

Singapore, Singapore, 308433

Wichita Falls, United States, 76301

Sterling Hospital

Ahmedabad, India, 380052

Hospital das Clinicas da UFPR

Curitiba, Brazil, 80060-150

3rd Hospital, Peking University

Beijing, China, 100083

Istanbul, Turkey, 34662

Clinica Las Condes

Santiago, Chile

Saskatoon, Canada, S7N 0W8

Wayne State University School of Medicine

Detroit, United States, 48201

Luebeck, Germany, 23538

University of Miami - Miller School of Medicine

Miami, United States, 33136

Idaho Falls, United States, 83404

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, 3000

Charles Lemoyne Hospital

Greenfield Park, Canada, J4V 2H1

General Hospital of Lanzhou Petrol -West

Lanzhou, China, 730060

Institut Jules Bordet

Brussels, Belgium, 1000

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, Hungary, 4032

Dijon, France, 21079

Charleston, United States, 29414

Hadassah Universtiy Hospital - Ein Kerem

Jerusalem, Israel, 91200

Aalst, Belgium, 9300

Hotel Dieu

Nantes Cedex 01, France, 44093

Bangkok, Thailand, 10400

Los Angeles Biomedical Research Institute at Harbor-UCLA Med

Torrance, United States, 90509

Vellore, India, 632004

University of California - Los Angeles

Los Angeles, United States, 90095

Hospital Dr. Hernan Henriquez Aravena

Temuco, Chile, 4780000

Newark, United States, 19718

Clínica de Los Virreyes

Ciudad Autonoma Bs As, Argentina, 1426

Capital Federal, Argentina, C1180AAV

Centre de Sante et des Services Sociaux de Chicoutimi

Chicoutimi, Canada, 67H5H6

Nanjing, China, 210029

Seoul, Republic of Korea, 120-752

Universitaetsklinikum Aachen

Aachen, Germany, 52074

University of Manchester

Manchester, United Kingdom, M13 9PT

Renji Hospital, Shanghai Jiatong University School of Medicine

Shanghai, China, 200025

Songkla, Thailand, 90110

Zurich, Switzerland, 8091

Songklanagarind Hospital

Hat Yai, Thailand, 90110

University of California Davis Health System

Sacramento, United States, 95817

Hospital Britanico de Buenos Aires

Ciudad Autonoma Bs As, Argentina, C1280AEB

Rafik Hariri Uni Hospital

Beirut, Lebanon, 5244

Buenos Aires, Argentina, C1181ACH

Bangkok, Thailand, 10700

Penn Memory Center

Philadelphia, United States, 19104

Porto Alegre, Brazil, 90035-003

Szegedi Tudomanyegyetem

Szeged, Hungary, 6720

Afula, Israel, 18101

Lima, Peru, 34

Petz Aladar Megyei Oktato Korhaz

Györ, Hungary, 9024

Winston Salem, United States, 27157

Deenanath Mangeshkar Hospital & Research Centre

Pune, India, 411004

Instituto Nacional de Cancerologia

Mexico, Mexico, 14080

CHU de Grenoble, Hôpital Michallon

Grenoble, France, 38043

Salamanca, Spain, 37007

Chennai, India, 60006

Sahyadri Hospital

Pune, India, 411004

Republican Hospital named after V.A. Baranov

Petrozavodsk, Russian Federation, 185019

Centre Hospitalier Lyon Sud

Pierre Bénite, France, 69495

Ain Shams University Hospital

Cairo, Egypt, 11566

Beirut, Lebanon, 1002807

Hospital Ampang

Ampang, Malaysia, 68000

ULB Hospital Erasme

Bruxelles, Belgium, 1070

Capital Federal, Argentina, C1280AEB

Cavite City, Philippines

Institute of Hematology and Hospital of Blood Disease

Tianjin, China, 300020

Ruijin Hospital, Shanghai Jiatong University School of Medicine

Shanghai, China, 200025

The Affiliated Union Hospital of Fujian Medical University

Fuzhou, China, 350001

Stanford University Hospital

Stanford, United States, 94303

Cochin, India, 682041

Maharat Nakhon Ratchasima Hospital

Muang, Thailand, 30000

Mexico, Mexico, 06726

Rio de Janeiro, Brazil, 21945-560

Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

Manipal, India, 576104

Manila, Philippines, 1000

Jehangir Clinical Development Centre Pvt. Ltd.

Pune, India, 411001

Hospital San Roque

Cordoba, Argentina, 5000

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosi, Mexico, 78240