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An interventional efficacy and safety Phase 3 double-blind 2-arm study to investigate IV followed by oral fosmanogepix compared with IV caspofungin followed by oral fluconazole in adult participants with candidemia and/or invasive candidiasis.

Status: Recruiting

The purpose of this study is to compare effects of the study drug fosmanogepix with already-approved drugs caspofungin and fluconazole to find out if fosmanogepix is safe and effective in treating patients with candidemia and/or invasive candidiasis.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of candidemia and/or invasive candidiasis
• see link to cliinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• require hemodialysis, peritoneal dialysis, or hemofiltration
• received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:

Drug: Caspofungin, Drug: Fluconazole, Drug: Fosmanogepix, Drug: Fosmanogepix, Drug: Placebo, Drug: Placebo, Drug: Placebo, Drug: Placebo

Conditions:

Infectious Diseases

Keywords:

Candidemia, fungal infection

Study Contact: Tyler Pham - pham0225@umn.edu
Principal Investigator: Jo-Anne Young, MD
Phase: PHASE3
IRB Number: STUDY00023155
See this study on ClinicalTrials.gov

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