A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
NCT ID: NCT05421858
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2024-12-11
2028-01-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fosmanogepix IV/oral
Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth.
Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).
Fosmanogepix
IV infusion
Fosmanogepix
Oral tablet
Placebo
Matching placebo for caspofungin (IV infusion)
Placebo
Matching placebo for fluconazole (oral capsule)
Caspofungin IV/ Fluconazole oral
Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth.
Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).
Caspofungin
IV infusion
Fluconazole
Fluconazole oral capsule
Placebo
Matching placebo for fosmanogepix (IV infusion)
Placebo
Matching placebo for fosmanogepix (oral tablet)
Interventions
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Fosmanogepix
IV infusion
Fosmanogepix
Oral tablet
Caspofungin
IV infusion
Fluconazole
Fluconazole oral capsule
Placebo
Matching placebo for caspofungin (IV infusion)
Placebo
Matching placebo for fluconazole (oral capsule)
Placebo
Matching placebo for fosmanogepix (IV infusion)
Placebo
Matching placebo for fosmanogepix (oral tablet)
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Exclusion Criteria
1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.
2. Inappropriate fungal infection source control.
3. Diagnosis of certain deep-seated Candida infections.
2. Life expectancy of \< 72 hours in the opinion of the investigator.
3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
5. Patients with known human immunodeficiency virus infection, who have CD4+ count \< 200/mm3 or viral load \> 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
10. Prior participation in this or any previous study of fosmanogepix.
11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
12. Female patient is pregnant or lactating.
13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.
18 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Manuel Häckl, MD
Role: STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Locations
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University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States
UC Davis Medical Center
Sacramento, California, United States
Emory University Hospital - Clifton Road
Atlanta, Georgia, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
University of Kentucky College of Medicine
Lexington, Kentucky, United States
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
Detroit, Michigan, United States
University of Minnesota
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
Houston Methodist Hospital - Texas Medical Center
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Central Hospital de San Isidro Melchor Posse
Buenos Aires, , Argentina
Buenos Aires Italian Hospital, Department of Infectious Diseases
Buenos Aires, , Argentina
Cordoba Private University Hospital, Department of Infectious Diseases
Córdoba, , Argentina
British Sanatorium SA
Rosario, , Argentina
Westmead Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Center, State
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Monash Medical Center Clayton
Clayton, , Australia
University Hospital Graz, Department of Internal Medicine
Graz, , Austria
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
Linz, , Austria
Medical University Vienna
Vienna, , Austria
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
Vienna, , Austria
General Hospital Saint-Jan
Bruges, , Belgium
University Hospital Brussels
Brussels, , Belgium
Saint Luc University Hospital, Department of Internal Medicine
Brussels, , Belgium
Erasme Hospital, Department of Infectious and Tropical Diseases
Brussels, , Belgium
Jessa Hospital
Hasselt, , Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
Leuven, , Belgium
UCL Mont-Godinne University Hospitals
Yvoir, , Belgium
Hospital Our Lady of Grace
Curitiba, Paraná, Brazil
Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine
Porto Alegre, Rio Grande do Sul, Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Santa Marcelina Hospital
São Paulo, , Brazil
Eurohospital University Hospital
Plovdiv, , Bulgaria
University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic
Sofia, , Bulgaria
University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery
Sofia, , Bulgaria
Somer Clinic
Rionegro, , Colombia
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
Amiens, , France
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
Argenteuil, , France
Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections
Marseille, , France
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, , France
Rennes University Hospital Center - Hospital Pontchaillou
Rennes, , France
Tours Regional University Hospital Center
Tours, , France
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
Ulm, Baden-Wurttemberg, Germany
University Hospital Regensburg
Regensburg, Bavaria, Germany
Frankfurt University Clinic
Frankfurt am Main, Hesse, Germany
University Hospital Giessen and Marburg GmbH
Giessen, Hesse, Germany
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
Cologne, North Rhine-Westphalia, Germany
University Hospital Heidelberg, Clinic for Anesthesiology
Heidelberg, , Germany
"LAIKO" General Hospital
Athens, , Greece
"Sotiria" Chest Diseases Hospital of Athens
Athens, , Greece
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
Athens, , Greece
Tzaneio General Hospital
Piraeus, , Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, , Greece
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, , Israel
Edith Wolfson Medical Center, Department of Infectious Diseases
Holon, , 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
Hospital "S. Croce e Carle"
Cuneo, , Italy
IRCCS Policlinic Hospital San Martino
Genoa, , Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, , Italy
Hospital San Raffaele, IRCCS
Milan, , Italy
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, , Italy
University Polyclinic Hospital of Modena
Modena, , Italy
Polyclinic San Matteo, IRCCS
Pavia, , Italy
University Hospital of Pisa
Pisa, , Italy
AOU Senese
Siena, , Italy
Giuliano Isontina University Health Authority
Trieste, , Italy
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Helen Joseph Hospital
Johannesburg, , South Africa
Milpark Hospital
Johannesburg, , South Africa
Ryexo Clinical Research
Pretoria, , South Africa
University of Pretoria / Steve Biko Academic Hospital
Pretoria, , South Africa
Practice of R Moodley and MI Sarvan - Umhlanga
Umhlanga, , South Africa
Kyungpook National University Hospital
Daegu, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
University Hospital Virgen Macarena
Seville, Andalusia, Spain
University Hospital Nuestra Senora de Valme
Seville, Andalusia, Spain
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, Spain
University Hospital Vall d'Hebron, Intensive Care Unit (ICU)
Barcelona, Catalonia, Spain
Hospital Clinic of Barcelona, Department of Infectious Diseases
Barcelona, Catalonia, Spain
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, Madrid, Spain
University Hospital Cruces
Barakaldo, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Vajira Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Countries
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Central Contacts
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Other Identifiers
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2022-500455-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
FMGX-CS-301
Identifier Type: -
Identifier Source: org_study_id