Actively Recruiting
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Led by Basilea Pharmaceutica · Updated on 2026-04-22
234
Participants Needed
49
Research Sites
127 weeks
Total Duration
On this page
Sponsors
B
Basilea Pharmaceutica
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults diagnosed with proven or probable invasive mold infection caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant molds
- Patient's condition allows for appropriate infection source control measures
You will not qualify if you...
- Refractory hematologic malignancy
- Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- COVID-19 associated mucormycosis
- Invasive fungal disease caused by more than one fungal pathogen (not allowed in Cohort A)
- Karnofsky Performance Status less than 20 at screening
- Need for or expected need for hemodialysis, peritoneal dialysis, or hemofiltration
- Known human immunodeficiency virus infection
- Ongoing neurological disorders
- Receiving hospice or comfort care only
- Other medical or psychiatric conditions
- Use of any prohibited concomitant medications
- Current or previous use of an investigational drug within 30 days
- Prior enrollment in this or any previous fosmanogepix study
- Moderate or severe liver impairment
- Pregnancy or lactation
- Known hypersensitivity to fosmanogepix, manogepix, or their excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States, 35294-0006
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1690
Actively Recruiting
4
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
5
University of Kentucky Medical Center, Division of Infectious Diseases
Lexington, Kentucky, United States, 40506
Actively Recruiting
6
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Actively Recruiting
7
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
8
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States, 48201
Actively Recruiting
9
University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
10
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, United States, 63110
Actively Recruiting
11
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
12
Duke University Medical Center, Duke Infectious Diseases
Durham, North Carolina, United States, 27710
Actively Recruiting
13
The University of Texas Health Science Center at Houston, Department of Internal Medicine
Houston, Texas, United States, 77030
Actively Recruiting
14
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Monash Medical Center Clayton
Clayton, Australia, 3168
Actively Recruiting
16
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
17
Peter MacCallum Cancer Center
Melbourne, Australia, 3050
Actively Recruiting
18
Royal Melbourne Hospital
Parkville, Australia, 3050
Actively Recruiting
19
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
20
Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology
Linz, Austria, 4021
Actively Recruiting
21
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine
Vienna, Austria, 1090
Actively Recruiting
22
Charleroi Grand Hospital (GHDC) - Les Viviers Site
Charleroi, Belgium, 6000
Actively Recruiting
23
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, Belgium, 3000
Actively Recruiting
24
UCL Mont-Godinne University Hospitals
Yvoir, Belgium, 5530
Actively Recruiting
25
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
26
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
27
Vancouver Coastal Health Research Institute (VCHRI)
Vancouver, Canada, V5Z 1M9
Actively Recruiting
28
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, France, 44000
Actively Recruiting
29
University Medical Center of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
30
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, Israel, 3109601
Actively Recruiting
31
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, Israel, 52621
Actively Recruiting
32
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, Israel, 6423906
Actively Recruiting
33
Shamir Medical Center, Department of Infectious Diseases
Ẕerifin, Israel, 7033001
Actively Recruiting
34
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, Italy, 20122
Actively Recruiting
35
University Polyclinic Hospital of Modena
Modena, Italy, 41124
Actively Recruiting
36
Polyclinic San Matteo, IRCCS
Pavia, Italy, 27100
Actively Recruiting
37
University Hospital of Pisa
Pisa, Italy, 56126
Actively Recruiting
38
Giuliano Isontina University Health Authority
Trieste, Italy, 34125
Actively Recruiting
39
Radboud University Medical Center (Radboudumc), Department of Intensive Care
Nijmegen, Netherlands, 6525GA
Actively Recruiting
40
Erasmus Medical Center, Deoartment of Infectious Diseases
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
41
University Hospital Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
42
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
43
University Hospital Cruces
Barakaldo, Spain, 48903
Actively Recruiting
44
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
45
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, Spain, 28034
Actively Recruiting
46
Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
47
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
48
Songklanagarind Hospital
Hat Yai, Thailand, 90110
Actively Recruiting
49
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Actively Recruiting
Research Team
A
Alison Kuchta, MD
CONTACT
M
Marc Engelhardt, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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