Actively Recruiting
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Led by Basilea Pharmaceutica · Updated on 2026-04-22
450
Participants Needed
138
Research Sites
163 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 clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital. The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%. The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.
CONDITIONS
Official Title
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older who provide informed consent or have a legal representative consent on their behalf
- Diagnosis of candidemia and/or invasive candidiasis confirmed by specimen within 4 days before randomization and clinical signs related to the infection
- Condition allows for infection source control, including removal of intravascular catheters if necessary
You will not qualify if you...
- Infection caused by Candida krusei in blood or sterile sites
- Inappropriate fungal infection source control
- Certain deep-seated Candida infections
- Life expectancy less than 72 hours as judged by investigator
- Need for or expected need for hemodialysis, peritoneal dialysis, or hemofiltration
- Ongoing neurological disorders with CTCAE Grade 2 or higher, except those related to current infection
- Known HIV infection with CD4+ count below 200/mm3 or viral load over 400 copies/mL, or active opportunistic infection within 6 months
- Other medical or psychiatric conditions or lab abnormalities increasing study risk or making participation unsuitable
- Use of prohibited medications or unwillingness/inability to use permitted medications
- More than 2 days of prior systemic antifungal treatment for current infection within 4 days before randomization, except specified cases
- Participation in investigational drug or vaccine studies within 30 days or 5 half-lives before study drug
- Prior participation in this or any previous fosmanogepix study
- Moderate or severe liver impairment, active hepatitis B or C, or elevated liver enzymes beyond specified limits unless due to Gilbert's syndrome
- Pregnant or lactating female patients
- Known allergy to fosmanogepix, manogepix, caspofungin, echinocandins, fluconazole, or their components
- Study staff involved in conduct of study and their family members excluded from participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 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
Actively Recruiting
4
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
5
Emory University Hospital - Clifton Road
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Augusta University Medical Center
Augusta, Georgia, United States, 30912-5563
Actively Recruiting
7
Indiana University Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Kentucky College of Medicine
Lexington, Kentucky, United States, 40506
Actively Recruiting
9
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
11
DMC Harper University Hospital
Detroit, Michigan, United States, 48201
Actively Recruiting
12
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
Detroit, Michigan, United States, 48202
Actively Recruiting
13
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
16
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
17
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-6243
Actively Recruiting
18
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213-2582
Actively Recruiting
19
Houston Methodist Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
20
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
21
U.T. MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
22
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
23
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
24
Central Hospital de San Isidro Melchor Posse
Buenos Aires, Argentina, B1641
Actively Recruiting
25
Buenos Aires Italian Hospital, Department of Infectious Diseases
Buenos Aires, Argentina, C1199ABB
Actively Recruiting
26
Cordoba Private University Hospital, Department of Infectious Diseases
Córdoba, Argentina, X5016KEH
Actively Recruiting
27
Italian Hospital of La Plata, Department of Infectious Diseases
La Plata, Argentina, B1900
Actively Recruiting
28
Central Hospital Mendoza
Mendoza, Argentina, M5500IDN
Actively Recruiting
29
British Sanatorium SA
Rosario, Argentina, S2000CVB
Actively Recruiting
30
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
31
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
32
Peter MacCallum Cancer Center, State
Melbourne, Victoria, Australia, 3000
Actively Recruiting
33
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
34
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
35
Monash Medical Center Clayton
Clayton, Australia, 3168
Actively Recruiting
36
University Hospital Graz, Department of Internal Medicine
Graz, Austria, 1100
Actively Recruiting
37
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
Linz, Austria, 4021
Actively Recruiting
38
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
39
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
Vienna, Austria, 1100
Actively Recruiting
40
General Hospital Saint-Jan
Bruges, Belgium, 8000
Actively Recruiting
41
University Hospital Brussels
Brussels, Belgium, 1090
Actively Recruiting
42
Saint Luc University Hospital, Department of Internal Medicine
Brussels, Belgium, 1200
Actively Recruiting
43
Erasme Hospital, Department of Infectious and Tropical Diseases
Brussels, Belgium, B-1070
Actively Recruiting
44
Jessa Hospital
Hasselt, Belgium, 3500
Actively Recruiting
45
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
Leuven, Belgium, 3000
Actively Recruiting
46
UCL Mont-Godinne University Hospitals
Yvoir, Belgium, 5530
Suspended
47
HC-UFPR
Curitiba, Paraná, Brazil, 80060-900
Actively Recruiting
48
Hospital Our Lady of Grace
Curitiba, Paraná, Brazil, 80810-040
Actively Recruiting
49
Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
50
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
51
Santa Marcelina Hospital
São Paulo, Brazil, 08270-070
Actively Recruiting
52
Eurohospital University Hospital
Plovdiv, Bulgaria, 4004
Actively Recruiting
53
University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic
Sofia, Bulgaria, 1606
Actively Recruiting
54
University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery
Sofia, Bulgaria, 1606
Actively Recruiting
55
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
56
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233099
Actively Recruiting
57
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510230
Actively Recruiting
58
Zhejiang Provincal Hospital of Chinese Medicine
Hangzhou, China, 310006
Actively Recruiting
59
Zhejiang Provincial People's Hospital
Hangzhou, China, 310014
Actively Recruiting
60
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, China, 310016
Actively Recruiting
61
Lishui People's Hospital
Lishui, China, 323000
Actively Recruiting
62
Liuzhou People's Hospital
Liuzhou, China, 530021
Actively Recruiting
63
The 1st Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
64
Qingyuan People's Hospital
Qingyuan, China, 511518
Actively Recruiting
65
Huashan Hospital
Shanghai, China, 200040
Actively Recruiting
66
Shenzhen Third People's Hospital
Shenzhen, China, 518112
Actively Recruiting
67
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China, 301617
Actively Recruiting
68
Wuxi People's Hospital
Wuxi, China, 214023
Actively Recruiting
69
Cardiomet CEQUIN Foundation, Department of Nephrology
Armenia, Colombia, 630004
Actively Recruiting
70
Luz Castro de Gutierrez Medellin General Hospital, Research Center
Medellín, Colombia, 050015
Actively Recruiting
71
Pablo Tobon Uribe Hospital
Medellín, Colombia, 050034
Actively Recruiting
72
High Technology Medical Institute S.A.S, IMAT S.A.S.
Montería, Colombia, 230002
Actively Recruiting
73
Somer Clinic
Rionegro, Colombia, 54040
Actively Recruiting
74
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
Amiens, France, 80054
Actively Recruiting
75
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
Argenteuil, France, 95107
Actively Recruiting
76
Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections
Marseille, France, 13015
Suspended
77
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, France, 44000
Actively Recruiting
78
Rennes University Hospital Center - Hospital Pontchaillou
Rennes, France, 35000
Actively Recruiting
79
Tours Regional University Hospital Center
Tours, France, 37000
Actively Recruiting
80
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
81
University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
82
Frankfurt University Clinic
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
83
University Hospital Giessen and Marburg GmbH
Giessen, Hesse, Germany, 35392
Actively Recruiting
84
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
85
University Hospital Heidelberg, Clinic for Anesthesiology
Heidelberg, Germany, 69120
Actively Recruiting
86
"LAIKO" General Hospital
Athens, Greece, 115 27
Actively Recruiting
87
"Sotiria" Chest Diseases Hospital of Athens
Athens, Greece, 11527
Suspended
88
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
Athens, Greece, PC 10676
Actively Recruiting
89
University General Hospital of Heraklion
Heraklion, Greece, 715 00
Actively Recruiting
90
Tzaneio General Hospital
Piraeus, Greece, 185 36
Suspended
91
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Greece, 54642
Actively Recruiting
92
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, Israel, 3109601
Actively Recruiting
93
Edith Wolfson Medical Center, Department of Infectious Diseases
Holon, Israel, 58100
Actively Recruiting
94
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, Israel, 52621
Actively Recruiting
95
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, Israel, 6423906
Actively Recruiting
96
Shamir Medical Center, Department of Infectious Diseases
Ẕerifin, Israel, 7033001
Actively Recruiting
97
Hospital "S. Croce e Carle"
Cuneo, Italy, 12100
Actively Recruiting
98
IRCCS Policlinic Hospital San Martino
Genoa, Italy, 16132
Actively Recruiting
99
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, Italy, 20122
Actively Recruiting
100
Hospital San Raffaele, IRCCS
Milan, Italy, 20132
Actively Recruiting
101
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, Italy, 20162
Actively Recruiting
102
University Polyclinic Hospital of Modena
Modena, Italy, 41124
Actively Recruiting
103
Polyclinic San Matteo, IRCCS
Pavia, Italy, 27100
Actively Recruiting
104
University Hospital of Pisa
Pisa, Italy, 56124
Actively Recruiting
105
AOU Senese
Siena, Italy, 53100
Actively Recruiting
106
Giuliano Isontina University Health Authority
Trieste, Italy, 34125
Actively Recruiting
107
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
108
Singapore General Hospital
Singapore, Singapore, 169608
Suspended
109
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Suspended
110
Helen Joseph Hospital
Johannesburg, South Africa, 2092
Actively Recruiting
111
Milpark Hospital
Johannesburg, South Africa, 2193
Suspended
112
Ryexo Clinical Research
Pretoria, South Africa, 0084
Withdrawn
113
University of Pretoria / Steve Biko Academic Hospital
Pretoria, South Africa, 0084
Actively Recruiting
114
Practice of R Moodley and MI Sarvan - Umhlanga
Umhlanga, South Africa, 4320
Actively Recruiting
115
Kyungpook National University Hospital
Daegu, South Korea, 41944
Suspended
116
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
117
Samsung Medical Center
Seoul, South Korea, 06351
Suspended
118
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
119
University Hospital Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
120
University Hospital Nuestra Senora de Valme
Seville, Andalusia, Spain, 41014
Actively Recruiting
121
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
122
University Hospital Vall d'Hebron, Intensive Care Unit (ICU)
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
123
Hospital Clinic of Barcelona, Department of Infectious Diseases
Barcelona, Catalonia, Spain, 08036
Suspended
124
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, Madrid, Spain, 28034
Actively Recruiting
125
University Hospital Cruces
Barakaldo, Spain, 48903
Actively Recruiting
126
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807377
Actively Recruiting
127
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833401
Actively Recruiting
128
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Actively Recruiting
129
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
130
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
131
Taipei Medical University Hospital
Taipei, Taiwan, 11000
Actively Recruiting
132
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
133
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Actively Recruiting
134
Vajira Hospital
Bangkok, Thailand, 10300
Actively Recruiting
135
Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
136
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
137
Songklanagarind Hospital
Hat Yai, Thailand, 90110
Actively Recruiting
138
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Actively Recruiting
Research Team
M
Manuel Häckl, MD
CONTACT
M
Marc Engelhardt, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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