Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

Who is this study for? Patients with invasive fungal disease caused by aspergillus species
Status: Recruiting
Location: See all (140) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female patients ages over 18 years and weighing more than 30 kg

• Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.

• Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.

• AmBisome® is an appropriate therapy for the patient.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
City of Hope National Medical Center
RECRUITING
Duarte
University of California Davis Health System
RECRUITING
Sacramento
UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITING
San Francisco
Florida
University of Florida
RECRUITING
Gainesville
Georgia
Augusta University
RECRUITING
Augusta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
NIH Clinical Center ,NIAID,NIH
RECRUITING
Bethesda
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke Department of Medicine Infectious Diseases Division
RECRUITING
Durham
New Jersey
Rutgers RWJMS
RECRUITING
New Brunswick
Nevada
Clairvoyant Research Group, LLC
TERMINATED
Las Vegas
New York
Weill Cornell Medicine NY Presbyterian Hospital
RECRUITING
New York
Oklahoma
OU Health OU Medical Center
RECRUITING
Oklahoma City
Pennsylvania
University of Pittsburgh Medical Center Health System
RECRUITING
Pittsburgh
Texas
Houston Methodist
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Australia
Royal Brisbane & Women's Hospital
RECRUITING
Herston
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Royal Melbourne Hospital
RECRUITING
Parkville
Royal NorthShore Hospital
RECRUITING
Saint Leonards
Belgium
AZ Sint-Jan
RECRUITING
Bruges
Hôpital Erasme
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Hospital Felício Rocho
TERMINATED
Belo Horizonte
Santa Casa de Misericórdia de Belo Horizonte
TERMINATED
Belo Horizonte
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
RECRUITING
Curitiba
Santa Casa de Misericórdia de Passos
RECRUITING
Passos
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
Hospital da Universidade Federal de Santa Maria CEP/UFSM
RECRUITING
Santa Maria
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Hamilton Health Sciences - Juravinski Site
RECRUITING
Hamilton
Toronto General Hospital
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
China
Peking University People's Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
The First Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital, Central South University
RECRUITING
Changsha
Chenzhou No.1 People's Hospital
RECRUITING
Chenzhou
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital of Zhejiang University school of medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Huashan Hospital Fudan University
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shengyang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The 1st Affiliated Hosp of Wenzhou Medical University
RECRUITING
Wenzhou
Huazhong University of Science and Technology
RECRUITING
Wuhan
Xi'an International Medical Center
RECRUITING
Xi'an
Institute of Hematology and Blood Diseases Hospital
RECRUITING
Xiaobailou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
France
CHU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
CHU de Besancon
RECRUITING
Besançon
CHU Bordeaux Hopital Saint André
RECRUITING
Bordeaux
Hospital Claude Huriez
RECRUITING
Lille
CHU de Nantes CIC Hematologie
RECRUITING
Nantes
Hôpital Necker - Enfants Malades
RECRUITING
Paris
CHU de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Institut de Cancérologie de Strasbourg Europe - ICANS
RECRUITING
Strasbourg
Institut Universitaire du Cancer de Toulouse- IUCT-O
RECRUITING
Toulouse
Germany
Charite Universitatsmedizin Berlin
RECRUITING
Berlin
Universitaetsklinikum Koeln
RECRUITING
Cologne
UKE Universitaetsklinikum-Hamburg Eppendorf
RECRUITING
Hamburg-eppendorf
Universitatsklinikum Leipzig
TERMINATED
Leipzig
Israel
Soroka University Medical Center
RECRUITING
Beersheba
Hadassah University Hospital - Ein Kerem
RECRUITING
Jerusalem
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center Pt
RECRUITING
Tel Aviv
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
AOU Policlinico di Modena
RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Azienda Ospedaliera Universitaria Luigi Vanvitelli
RECRUITING
Napoli
Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università
RECRUITING
Perugia
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Inmi Lazzaro Spallanzani Irccs
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
RECRUITING
Bunkyō City
Chiba University Hospital
RECRUITING
Chiba
Kyushu University Hospital
RECRUITING
Fukuoka
The Jikei University Hospital
RECRUITING
Minato-ku
Toranomon Hospital
RECRUITING
Minatoku
Nagasaki University Hospital
RECRUITING
Nagasaki
Okayama University Hospital
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Ōsaka-sayama
Saitama Medical Center Jichi Medical University
RECRUITING
Saitama
Tohoku University Hospital
RECRUITING
Sendai
Jichi Medical University Hospital
RECRUITING
Shimotsuke
Netherlands
Radboud Nijmegen
RECRUITING
Nijmegen
UMC Utrecht
RECRUITING
Utrecht
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Wellington Regional Hospital
RECRUITING
Newtown
Republic of Korea
The Catholic University of Korea
RECRUITING
Bucheon-si
Samsung Medical Center
RECRUITING
Irwon-dong
Singapore
National University Hospital
RECRUITING
Singapore
Singapore General Hospital- Parent
RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
RECRUITING
Retiro
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
TERMINATED
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Thailand
Siriraj Hospital
RECRUITING
Bangkok Noi
Srinagarind Hospital
RECRUITING
Khon Kaen
Turkey
Ankara City Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty
RECRUITING
Ankara
Dicle University, Medical Faculty
RECRUITING
Diyarbakır
Acibadem Atakent Hospital
RECRUITING
Istanbul
Ege University Medical Faculty
RECRUITING
Izmir
Ondokuz Mayis Univ. Med. Fac.
RECRUITING
Samsun
United Kingdom
University Hospital of Wales
RECRUITING
Cardiff
Imperial College London
RECRUITING
London
Kings College Hospital
RECRUITING
London
Contact Information
Primary
Daniela Zinzi, MD
DZinzi@f2g.com
+43 06643582281
Time Frame
Start Date: 2022-03-31
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 225
Treatments
Active_comparator: Olorofim
Olorofim versus AmBisome followed by Standard of Care (SOC)
Active_comparator: AmBisome
Olorofim versus AmBisome followed by Standard of Care (SOC)
Related Therapeutic Areas
Sponsors
Collaborators: Iqvia Pty Ltd, Shionogi
Leads: F2G Biotech GmbH

This content was sourced from clinicaltrials.gov

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