Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
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
3 other identifiers
interventional
450
25 countries
113
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2007
Longer than P75 for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedStudy Start
First participant enrolled
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2015
CompletedResults Posted
Study results publicly available
August 1, 2017
CompletedDecember 10, 2024
November 1, 2024
8 years
December 18, 2006
July 5, 2017
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use
A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.
End of Intravenous Treatment (EOIV) (Days 11-56)
Secondary Outcomes (8)
Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)
End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)
Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2
EOT (Day 56) and FU2 (6 weeks after end of treatment)
Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
Day 7 and EOT (Day 56)
- +3 more secondary outcomes
Study Arms (2)
Isavuconazole (ISA)
EXPERIMENTALParticipants 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.
Caspofungin (CAS)/Voriconazole
ACTIVE COMPARATORParticipants 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.
Interventions
Administered by intravenous infusion.
Administered by intravenous infusion.
Administered by intravenous infusion.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Basilea Pharmaceuticacollaborator
Study Sites (113)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006, United States
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
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
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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 City, 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
Temple University Health Sciences
Philadelphia, Pennsylvania, 19140, United States
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
ULB Hôpital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Hospital Felicio Rocho
Belo Horizonte, 30110-908, Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerai
Belo Horizonte, 30130-100, 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
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
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
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
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
Vandœuvre-lès-Nancy, 54511, France
Charite Campus Mitte
Berlin, 10117, Germany
Universitaet Koeln
Cologne, 50937, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Klinikum St. Georg
Leipzig, 04129, Germany
Universitaetsklinik Leipzig
Leipzig, 04289, Germany
Universitaetsklinikum Leipzig
Lübeck, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
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
Kochi, Kerala, 682041, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Mahara, 411004, India
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110017, India
Metro Centre for Respiratory Diseases
Noida, National Capital Territory of Delhi, 201301, India
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
Ente Ospedaliero Ospedeli Galliera
Genova, 16128, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, 16132, 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 Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Hospital Civil de Guadalajara Dr Juan I Menchaca
Guadalajara, 44340, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador
México, 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, Russia
State Institution "Hematology Research Center" RAMS
Moscow, 125167, Russia
Singapore General Hospital - Parent
Singapore, 169608, Singapore
National Neuroscience Institute
Singapore, 308433, 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
Maharat Nakhon Ratchasima Hospital
Muang, 30000, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, 50200, Thailand
Ramathibodi Hospital
Ratchathewi, 10400, Thailand
Related Publications (2)
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.
PMID: 30289478DERIVEDMcCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.
PMID: 25902926DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment in the clinical study was suspended in January 2009 pending further characterization of newly identified impurities. After successful completion of the studies, regulatory notifications and transfer of sponsorship from Basilea to Astellas,
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
March 8, 2007
Primary Completion
March 3, 2015
Study Completion
March 3, 2015
Last Updated
December 10, 2024
Results First Posted
August 1, 2017
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.