A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Inva… (NCT06925321) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
United States234 participantsStarted 2025-08-26
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.
The patient will be assigned to one of two treatment cohorts:
Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.
Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug
The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Refractory hematologic malignancy.
✕. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.