A Study to Learn About the Study Medicine (Called Fosmanogepix/ PF-07842805) in People With Candidemia and/or Invasive Candidiasis.

A Study to Learn About the Study Medicine (Called Fosmanogepix/ PF-07842805) in People With Candidemia and/or Invasive Candidiasis.

AN INTERVENTIONAL EFFICACY AND SAFETY PHASE 3 DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE IV FOLLOWED BY ORAL FOSMANOGEPIX (PF-07842805) COMPARED WITH IV CASPOFUNGIN FOLLOWED BY ORAL FLUCONAZOLE IN ADULT PARTICIPANTS WITH CANDIDEMIA AND/OR INVASIVE CANDIDIASIS.

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.

Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein in the arm. 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).

Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein in the arm. 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).

Proportion of participants with an overall response of Treatment Success- European Medicines Agency (EMA)/Japan

Proportion of participants with an overall response of Treatment Success (sustained) at follow up visit

Time to first negative blood culture in participants on fosmanogepix compared to caspofungin/fluconazole

Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), and treatment-related adverse events (AEs) and AEs leading to discontinuation

Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35 post-dose; EOST: 72 and 192 hours post-dose

Inclusion Criteria: Diagnosis of candidemia and/or invasive candidiasis defined by: A culture positive for yeast or Candida species, a positive Gram stain (or other method of direct microscopy) for yeast from blood or specimen from a normally sterile site, or a positive result for Candida using a Sponsor-approved rapid diagnostic test from a blood sample. Presence of one or more clinical criteria attributable to candidemia/invasive candidiasis: fever, hypothermia, hypotension, tachypnea ,tachycardia, and local signs associated with organ/site infected with Candida, and/or radiologic findings suggesting invasive candidiasis. Exclusion Criteria: Existing infections including: infections due to Candida krusei (in blood or any other normally sterile site), inappropriate fungal infection source control, diagnosis of certain deep-seated Candida infections, or temporally related proven bacterial infection at the same or contiguous infection site. Requirement, or expected requirement, for hemodialysis Received greater than 2 days equivalent of prior systemic antifungal treatment to treat the current episode of candidemia, within the 96 hours before to study enrolment.

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.