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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 participants who have a diagnosis of candidemia or invasive candidiasis.
Two-thirds of all participants will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all participants will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.
Fosmaogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmaogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if participants are well enough to be discharged from the hospital.
We will compare the experience of people receiving fosmanogepix to those receiving caspofungin/ fluconazole. This will help us determine if fosmanogepix is safe and effective.
Participants will continue treatment for a maximum of 6 weeks depending on whether the infection has cleared and whether the symptoms related to the infection has improved. During this time, they will have study visits for up to 10 times. There will also be a follow-up visit 6 weeks after the study treatment was stopped.
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Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
Candidemia, Candidiasis, Invasive
Sex
Male or Female
Age
18+ years