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.

Candidemia, Invasive candidiasis

Proportion of patients with an overall response of treatment success at end of study treatment (EOST). Time Frame: EOST (up to Day 42)

1. Proportion of patients alive at Day 30. Time Frame: Day 30, 2. Proportion of patients with overall response of treatment success at Day 7. Time Frame: Day 7, 3. Proportion of patients with an overall response of treatment success at Day 14. Time Frame: Day 14, 4. Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV). Time Frame: up to Day 42, 5. Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST. Time Frame: approximately up to 12,5 weeks, 6. Proportion of patients with clinical response of success at Day 7, Day 14, EOIV, EOST, Follow-up 6- weeks after EOST. Time Frame: Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST, 7. Proportion of patients with mycological response of eradication or presumed eradication at Day 7, Day 14, EOIV, EOST, Follow-up 6-weeks after EOST. Time Frame: Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST, 8. Time to first negative blood culture in patients on fosmanogepix compared to caspofungin/fluconazole. Time Frame: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks), 9. Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest (AESI)and AEs leading to discontinuation. Time Frame: Screening up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks), 10. Number of patients with clinically significant laboratory abnormalities. Time Frame: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks), 11. Number of patients with abnormal neurological examination findings. Time Frame: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks), 12. Assessment of 12-lead electrocardiogram (ECGs). Time Frame: Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks), 13. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety). Time Frame: Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35; EOST: 72 and 192 hours post-dose

No related papers found yet.

Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Spain