Last updated 27 days ago
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
234 patients around the world
Available in United States, Brazil
Basilea Pharmaceutica
3Research sites
234Patients around the world
This study is for people with
Fungal Infections
Invasive Mold Infections
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.Patient's condition allows for appropriate infection source control measures.
- Refractory hematologic malignancy.Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.Coronavirus disease 2019 (COVID-19) associated mucormycosis.Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.Patients with a Karnofsky Performance Status < 20 at Screening.Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.Patients with known human immunodeficiency virus infection.Ongoing neurological disorders.Patients receiving hospice/comfort care only.Other medical or psychiatric condition.Current use of any prohibited concomitant medication(s).Current/ previous administration of an investigational drug within 30 days.Prior enrollment in this or any previous study of fosmanogepix.Moderate or severe hepatic impairment.Patient who is pregnant or lactating.Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
Sites
Hospital de Clínicas de Porto Alegre (HCPA)
Recruiting
AC Camargo Cancer Center
Recruiting
Hospital Santa Marcelina
Recruiting
SponsorBasilea Pharmaceutica
Study typeInterventional
Conditions
Invasive Mold Infections
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06925321
