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.
Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
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.
Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Existing infection
Infection known to be due to Candida krusei, in blood or any other normally sterile site.
Inappropriate fungal infection source control.
Diagnosis of certain deep-seated Candida infections.
Parallel
Fosmanogepix
DrugIV infusion
Fosmanogepix
DrugOral tablet
Caspofungin
DrugIV infusion
Fluconazole
DrugFluconazole oral capsule
Placebo
DrugMatching placebo for caspofungin (IV infusion)
Placebo
DrugMatching placebo for fluconazole (oral capsule)
Placebo
DrugMatching placebo for fosmanogepix (IV infusion)
Placebo
DrugMatching placebo for fosmanogepix (oral tablet)
Proportion of patients alive at Day 30
Proportion of patients with an overall response of treatment success at end of study treatment (EOST)
Proportion of patients with an overall response of treatment success at Day 7
Proportion of patients with an overall response of treatment success at Day 14
Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV)
Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST
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Basilea Pharmaceutica
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
