Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
NCT ID: NCT00413218
Last Updated: 2024-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2007-03-08
2015-03-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Isavuconazole (ISA)
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.
Isavuconazole
Administered by intravenous infusion.
Caspofungin (CAS)/Voriconazole
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.
Caspofungin
Administered by intravenous infusion.
Voriconazole
Administered by intravenous infusion.
Interventions
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Isavuconazole
Administered by intravenous infusion.
Caspofungin
Administered by intravenous infusion.
Voriconazole
Administered by intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Basilea Pharmaceutica
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Somero Research Corporation
Palm Desert, California, United States
University of California Davis Health System
Sacramento, California, United States
University of California at San Francisco
San Francisco, California, United States
Idaho Falls Infectious Diseases PLLC
Idaho Falls, Idaho, United States
Loyola University Hospital
Maywood, Illinois, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Infectious Disease of Indiana
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mercury Street Medical Group
Butte, Montana, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, United States
Temple University Health Sciences
Philadelphia, Pennsylvania, United States
Hospital Britanico de Buenos Aires
Capital Federal, , Argentina
Hospital General de Agudos Dr. Carlos G. Durand
Capital Federal, , Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, , Argentina
Hospital General de Agudos Dr. Cosme Argerich
La Boca, , Argentina
Fremantle Hospital
Fremantle, , Australia
Mater Adult Hospital
South Brisbane, , Australia
Westmead Hospital
Westmead, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Institut Jules Bordet
Brussels, , Belgium
ULB Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Hospital Felicio Rocho
Belo Horizonte, , Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerai
Belo Horizonte, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital das Clinicas da UFPR
Curitiba, , Brazil
Hospital Nossa Senhora das Gracas
Curitiba, , Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
Hospital Universitario de Santa Maria
Santa Maria, , Brazil
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, , Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Hospital Dr. Sotero del Rio
Puente Alto Santiago, , Chile
Hospital del Salvador
Santiago, , Chile
Hospital Dr. Hernan Henriquez Aravena
Temuco, , Chile
West China Hospital of Sichuan University
Chengdu, , China
Huashan Hospital Fudan University
Shanghai, , China
Hôpital Hautepierre
Strasbourg, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Charite Campus Mitte
Berlin, , Germany
Universitaet Koeln
Cologne, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Klinikum St. Georg
Leipzig, , Germany
Universitaetsklinik Leipzig
Leipzig, , Germany
Universitaetsklinikum Leipzig
Lübeck, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Kasturba Medical College and Hospital
Mangalore, Karna, India
Kasturba Medical College K. M. C. Hospital
Manipal, Karna, India
Amrita Institute Of Medical Science
Kochi, Kerala, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Mahara, India
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, India
Metro Centre for Respiratory Diseases
Noida, National Capital Territory of Delhi, India
Apollo Hospitals Educational & Research Foundation
Chennai, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
AMRI Hospital
Kolkata, , India
Christian Medical College & Hospital
Vellore Tamilnadu, , India
Ha Emek Medical Center
Afula, , Israel
Rambam Health Care Campus
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, , Israel
Sapir Medical Center, Meir Hospital
Kfar Saba, , Israel
Rabin MC
Petah, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Ente Ospedaliero Ospedeli Galliera
Genova, , Italy
Azienda Ospedaliero Universitaria San Martino
Genova, , Italy
Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
Verona, , Italy
AUB Medical Center
Beirut, , Lebanon
Rafik Hariri Uni Hospital
Beirut, , Lebanon
Hospital Ampang
Ampang, , Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, , Mexico
Hospital Civil de Guadalajara Dr Juan I Menchaca
Guadalajara, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
México, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , 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, , Russia
State Institution "Hematology Research Center" RAMS
Moscow, , Russia
Singapore General Hospital - Parent
Singapore, , Singapore
National Neuroscience Institute
Singapore, , Singapore
Unitas Hospital
Lyttelton Centurion, , South Africa
Hospital del Mar
Barcelona, , Spain
Hôpitaux Universitaires de Genève - HUG
Geneva, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Siriraj Hospital
Bangkoknoi, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Maharat Nakhon Ratchasima Hospital
Muang, , Thailand
Srinagarind Hospital
Muang, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, , Thailand
Ramathibodi Hospital
Ratchathewi, , Thailand
Countries
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References
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Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.
McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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WSA-CS-008
Identifier Type: OTHER
Identifier Source: secondary_id
2006-003951-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9766-CL-0105
Identifier Type: -
Identifier Source: org_study_id
NCT00444366
Identifier Type: -
Identifier Source: nct_alias