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

• Status: Not yet recruiting
• Trial end date: 2026-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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 4 weeks after the study treatment was stopped.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Caspofungin; Fluconazole

Criteria

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.