Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Sponsor: Basilea Pharmaceutica
Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Official title: An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2025-08-26
Completion Date
2028-02
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Standard of care antifungal therapy
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Locations (41)
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Kentucky Medical Center, Division of Infectious Diseases
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States
University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center, Duke Infectious Diseases
Durham, North Carolina, United States
The University of Texas Health Science Center at Houston, Department of Internal Medicine
Houston, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Monash Medical Center Clayton
Clayton, Australia
The Alfred Hospital
Melbourne, Australia
Peter MacCallum Cancer Center
Melbourne, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology
Linz, Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine
Vienna, Austria
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, Belgium
University of Alberta
Edmonton, Alberta, Canada
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, Canada
Vancouver Coastal Health Research Institute (VCHRI)
Vancouver, Canada
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, France
University Medical Center of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, Israel
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, Israel
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, Israel
Shamir Medical Center, Department of Infectious Diseases
Ẕerifin, Israel
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, Italy
Polyclinic San Matteo, IRCCS
Pavia, Italy
University Hospital of Pisa
Pisa, Italy
Giuliano Isontina University Health Authority
Trieste, Italy
Erasmus Medical Center, Deoartment of Infectious Diseases
Rotterdam, Netherlands
University Hospital Virgen Macarena
Seville, Andalusia, Spain
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, Spain
Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Songklanagarind Hospital
Hat Yai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand