FAST-IC

Summary

Candida is a common yeast (fungus). It lives naturally in small amounts on the skin and in the body. Sometimes, the yeast grows out of control and causes an infection (candidiasis). Usually candidiasis is a minor infection of specific body locations, like the mouth (where it causes thrush) or vagina (vaginal yeast infections).

However, occasionally Candida organisms get into the bloodstream (candidemia). When that happens, they can spread throughout the body. Invasive candidiasis infections can cause severe complications, like kidney and eye problems, inflammation around the heart, and damage to the brain and spinal cord (meningitis). Even with the best current treatment, invasive candidiasis can cause organs to shut down, leading to death in about 30% of patients. In addition, infection survivors may have long-term consequences that affect their quality of life.

A new medication, fosmanogepix, may provide a much-needed treatment alternative for Candida infections. Fosmanogepix can be given through an IV, which typically happens in the hospital, and is available as pills, which is helpful for outpatient treatment.

The FAST-IC study explores the safety and efficacy of fosmanogepix for treating adults who have fungal infections due to the yeast Candida. Eligible patients who participate in FAST-IC are assigned randomly (50:50, like tossing a coin) to receive either fosmanogepix or the current standard treatment. Neither the lead scientist nor the participant can choose or know which treatment they receive. Regardless of which medication they get, participants continue treatment until their infection is under control. Participants can expect to be involved in FAST-IC treatment activities for a maximum of 6 weeks. Then participants have a final follow-up visit with research team members at 6 weeks after completing the study treatment.

To be included in FAST-IC, participants must be / have

• Adult (18 years old or older)
• Diagnosis of candidemia or invasive candidiasis according to positive culture and clinical criteria

To be included in FAST-IC, participants must not be / have

• Infection due to C krusei
• Hemodialysis, peritoneal dialysis, or hemofiltration needed or anticipated
• Some ongoing neurological disorders
• Already received at least 48 hours of systemic antifungal treatment for the current episode

Keywords
Candida; Candidiasis; Candidemia; FMGX-CS-301; Fungal infection