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Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

This study is currently Recruiting

November 2011 By Astellas Pharma Inc

First Recieved on March 5, 2008

Last Updated on November 9, 2011

Sponsor: Astellas Pharma Inc
Collaborators: Basilea Pharmaceutica
Information provided by: Astellas Pharma Inc
Identifier: NCT00634049

Purpose

The purpose of this study is to investigate the safety and efficacy of isavuconazole in the treatment of invasive fungal infections that are caused by Aspergillus (in renally impaired patients)and rare fungi.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - patients with proven/probable invasive fungal disease caused by Aspergillus and who have also renal impairment - patients with proven/probable invasive fungal disease caused by rare moulds, yeasts and dimorphic fungi Exclusion Criteria: - a known condition of the patient that may jeopardize adherence to the protocol requirements - Patients who are unlikely to survive 30 days - Patients with a body weight < 40 kg - Women who are pregnant or breastfeeding

Investigators

  • Investigator: Medical Director - Study Director - Astellas Pharma Global Development

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294 United States

  • City Of Hope National Medical Center

    Duarte, California 91010 United States

  • University of California - Los Angeles

    Los Angeles, California 90095 United States

  • University of California Davis Health System

    Sacramento, California 95817 United States

  • San Francisco, California 94115 United States

  • California Pacific Medical Center

    San Francisco, California 94110 United States

  • University of California at San Francisco

    San Francisco, California 94143 United States

  • Stanford, California 94305 United States

  • Stanford University Hospital

    Stanford, California 94303 United States

  • University Of Colorado Health Sciences Center

    Aurora, Colorado 80045 United States

  • Emory Hospital

    Atlanta, Georgia 30322 United States

  • University of Chicago, Division of Infectious Diseases

    Chicago, Illinois 60637 United States

  • Rush University Medical Center

    Chicago, Illinois 60612 United States

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana 46107 United States

  • Infectious Disease of Indiana

    Indianapolis, Indiana 46280 United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121 United States

  • Brigham & Womens Hospital

    Boston, Massachusetts 02115 United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts 01655 United States

  • Henry Ford Hospital

    Detroit, Michigan 48202 United States

  • Wayne State University School of Medicine

    Detroit, Michigan 48201 United States

  • University of Minnesota

    Minneapolis, Minnesota 55455 United States

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198 United States

  • Upstate Infectious Diseases Association LLP

    Albany, New York 12208 United States

  • Sloan Kettering Cancer Center

    New York, New York 10065 United States

  • New York Medical College

    Valhalla, New York 10595 United States

  • Cleveland Clinic

    Cleveland, Ohio 44195 United States

  • Remington-Davis Inc.

    Columbus, Ohio 43215 United States

  • Regional Infection Diseases Infusion Center Inc.

    Lima, Ohio 45801 United States

  • Bend Memorial Clinic

    Bend, Oregon 97701 United States

  • Oregon Health & Science University

    Portland, Oregon 97239 United States

  • Temple University Health Sciences

    Philadelphia, Pennsylvania 19140 United States

  • Penn Memory Center

    Philadelphia, Pennsylvania 19104 United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104 United States

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania 15213 United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030 United States

  • Fred Hutchinson Cancer Research Center, Clinical Research

    Seattle, Washington 98109 United States

  • Madison, Wisconsin 53792 United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 53705 United States

  • Buenos Aires, Argentina

  • Buenos Aires, 1702 Argentina

  • Buenos Aires, C1157ADP Argentina

  • Capital Federal, C1180AAV Argentina

  • Capital Federal, C1280AEB Argentina

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma, 1181 Argentina

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma, 1426 Argentina

  • Hospital San Roque

    Cordoba, 5000 Argentina

  • Hospital Nuestra Senora de la Misericordia

    Cordoba, 5000 Argentina

  • Hospital Italiano de La Plata

    La Plata, 1900 Argentina

  • Pilar, B1664INZ Argentina

  • Centro Polivalente de Asistencia e Investigaci?n Cl?nica - CER San Juan

    San Juan, 5402 Argentina

  • Milton, 4064 Australia

  • Mater Medical Centre

    South Brisbane, 4101 Australia

  • Princess Alexandria Hospital

    Woolloongabba, 4102 Australia

  • Aalst, 9300 Belgium

  • Brugge, 8000 Belgium

  • Institut Jules Bordet

    Brussels, 1000 Belgium

  • Erasme Hospital

    Bruxelles, 1070 Belgium

  • Universitair Ziekenhuis Gent

    Gent, 9000 Belgium

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000 Belgium

  • Felicio Rocho

    Belo Horizonte, 30110-908 Brazil

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221 Brazil

  • Hospital das Clinicas da Universidade Federal de Minas Gerai

    Belo Horizonte, 30130-100 Brazil

  • Hospital das Clinicas da UFPR

    Curitiba, 80060-150 Brazil

  • Hospital de Clinicas da FMUSP - Ribeirao Preto

    Ribeirao Preto, 14048-900 Brazil

  • Hospital Universitario Clementino Fraga Filho

    Rio de Janeiro, 21941-913 Brazil

  • Hospital Universitario de Santa Maria

    Santa Maria, 97105-900 Brazil

  • Hospital de Baso de Sao Jose do Rio Preto

    Sao Jose do Rio Preto, 15090-000 Brazil

  • Hospital Professor Edmundo Vasconcelos

    S?o Paulo, 04038-905 Brazil

  • Hamilton Health Sciences - Henderson Site

    Hamilton, Ontario L8V 1C3 Canada

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6 Canada

  • H?pital Maisonneuve - Rosemont

    Montreal, Quebec H1T 2M4 Canada

  • Saskatoon, Saskatchewan S7N 0W8 Canada

  • Hospital Clinico San Borja Arriaran

    Santiago, 8320000 Chile

  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

    Shanghai, 200025 China

  • Wuhan Union Hospital

    Wuhan, 430022 China

  • Alexandria University Hospital

    Alexandria, 21131 Egypt

  • National Cancer Institute

    Cairo, 11796 Egypt

  • Ain Shams University Hospital

    Cairo, 11566 Egypt

  • Nasser Institute

    Cairo, 12655 Egypt

  • CHU de Grenoble, H?pital Michallon

    Grenoble, 38043 France

  • H?pital Edouard Herriot

    Lyon cedex 3, 69437 France

  • Institut Paoli Calmette - Marseille

    Marseille Cedex 9, 13273 France

  • CHU de Nantes - H?pital H?tel Dieu

    Nantes Cedex, 44035 France

  • H?pital Saint-Louis

    Paris Cedex 10, 75475 France

  • Hopitl Saint-Antoine

    Paris Cedex 12, 75571 France

  • Hopital Hautepierre

    Strasbourg Cedex, 67098 France

  • H?pital de brabois adultes

    Vandoeuvre les Nancy, 54511 France

  • Universitaetsklinikum Aachen

    Aachen, 52074 Germany

  • Berlin, 10117 Germany

  • Charit? Universitaetsmedizin Berlin- Campus Charit? Mitte

    Berlin, 12200 Germany

  • Universitaet Koeln

    K?ln, 50931 Germany

  • Leipzig, 04129 Germany

  • Universitaetsklinik Leipzig

    Leipzig, 04289 Germany

  • L?beck, 23538 Germany

  • Klinikum Schwabing

    Muenchen, 81737 Germany

  • Medizinische klinik und Polyklinik II

    W?rzburg, 97080 Germany

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032 Hungary

  • Petz Aladar Megyei Oktato Korhaz

    Gyor, 9024 Hungary

  • Szegedi Tudomanyegyetem

    Szeged, 6720 Hungary

  • Hyderabad, Andh Prad 500082 India

  • Ahmedabad, Gujara Prad 380016 India

  • Medanta Medicity Hospital

    Gurgaon, Haryan 122001 India

  • Mangalore, Kama 575001 India

  • K. M. C. Hospital

    Manipal, Kama 576104 India

  • Tata Memorial Hopital, Department of Anesthesia

    Mumbai, Mahara 400012 India

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Mahara 411004 India

  • Global Hospitals & Health City

    Chennai, Tamilna 600100 India

  • Noida, Uttar Prad 201301 India

  • Kolkata, West Bengal 700029 India

  • Sterling Hospital

    Ahmedabad, 380052 India

  • Apollo Hospitals

    Hyderabad, 500033 India

  • Sahyadri Hospital

    Pune, 411004 India

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, 411001 India

  • Afula, 18101 Israel

  • Rambam Health Care Campus

    Haifa, 31096 Israel

  • Hadassah Universtiy Hospital - Ein Kerem

    Jerusalem, 91200 Israel

  • Rabin MC

    Petah Tikva, 49100 Israel

  • Chaim Sheba Medical Center

    Ramat-Gan, 52621 Israel

  • Sourasky MC Ichilov Hospital Tel Aviv

    Tel Aviv, 64239 Israel

  • Unit? Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi

    Firenze, 50134 Italy

  • Milano, 20162 Italy

  • Torino, 10126 Italy

  • Seoul, 120752 Korea, Republic of

  • The Catholic University of Korea

    Seoul, 137-701 Korea, Republic of

  • Asan Medical Center

    Seoul, 138-736 Korea, Republic of

  • Samsung Medical Center

    Seoul, 135-710 Korea, Republic of

  • AUB Medical Center

    Beirut, 11-0236 Lebanon

  • Clinique Rizk Hospital

    Beirut, 1107-2310 Lebanon

  • Rafik Hariri Uni Hospital

    Beirut, 5244 Lebanon

  • Ampang, 68000 Malaysia

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280 Mexico

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador

    Mexico City, 14000 Mexico

  • Mexico City, 14080 Mexico

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460 Mexico

  • Hamilton, 3204 New Zealand

  • Cavite City, 4114 Philippines

  • Gdansk, 80952 Poland

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warszawa, 02097 Poland

  • State Institution "Hematology Research Center" RAMS

    Moscow, 125167 Russian Federation

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

    Moscow, 115478 Russian Federation

  • Republican Hospital named after V.A. Baranov

    Petrozavodsk, 185019 Russian Federation

  • St-Petersburg MA Postgraduate Education

    St. Petersburg, 194291 Russian Federation

  • Dr H J van Rensburg

    Lyttleton, Gauteng 0157 South Africa

  • 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 Manchester

    Manchester, M13 9PT United Kingdom

  • University Hospital of South Manchester NHS Foundation Trust

    Manchester, M23 9LT United Kingdom

Conditions related to this trial:

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