A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 (Turletricin) versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy of Invasive Mould Infections (TREAT-1)

Condition studied

Suspected Invasive Mould Infection

Investigational medicinal product(s)

Eligibility

Primary endpoint

1_All-cause mortality at Day 21(±3 days) in the Intent-to-Treat (ITT) analysis set, 2_During the blinded portion of the study, Serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) categorized in a tiered approach in the Safety analysis set. Tier1 TEAEs include renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity. Tier 2 includes all other TEAEs

Endpoint detail

1_Overall success at Day 42, (±7 days), determined by the Data Review Committee (DRC), in the population with proven or probable IA (modified Intent-to-Treat [mITT]) as measured by: - Participant is alive, - favorable composite clinical, mycologic, and radiographic response (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria), 2_Early antifungal therapy (EAT) success at Day 21 (±3 days) in the ITT analysis set, defined by non-occurrence of the following: - Death - Cessation of study antifungals for progression of IMI, and/or toxicity - Missing data (classified as indeterminate but analyzed as a failure)