Condition: Candidemia · Candidiasis, Invasive · Sponsor: Basilea Pharmaceutica
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 …
This description comes directly from the study's public registry record.
Manuel Häckl, MD · +41 76 302 53 10 · manuel.haeckl@basilea.com
Marc Engelhardt, MD · +41 79 701 0551 · marc.engelhardt@basilea.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham School of Medicine, Department of Medicine | Birmingham, Alabama, United States | Recruiting |
| City of Hope | Duarte, California, United States | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles, California, United States | Suspended |
| UC Davis Medical Center | Sacramento, California, United States | Recruiting |
| Emory University Hospital - Clifton Road | Atlanta, Georgia, United States | Recruiting |
| Augusta University Medical Center | Augusta, Georgia, United States | Recruiting |
| Indiana University Methodist Hospital | Indianapolis, Indiana, United States | Recruiting |
| University of Kentucky College of Medicine | Lexington, Kentucky, United States | Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Recruiting |
| University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center | Ann Arbor, Michigan, United States | Recruiting |
| DMC Harper University Hospital | Detroit, Michigan, United States | Recruiting |
| Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases | Detroit, Michigan, United States | Recruiting |
+ 132 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05421858