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An interventional Phase 3, open-label, two-cohort study to investigate the efficacy and safety of fosmanogepix in adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
Status: Recruiting
The purpose of this study is to compare the effects of the study drug fosmanogepix with that of other currently approved treatments to find out if fosmanogepix is safe and effective in treating participants with invasive mold infections. Participants will be assigned to one of two groups depending on the study treatment already received for the current mold infection. Participation in this study will be for a maximum of 8 months.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of proven or probable Invasive mold infection
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• need or anticipated need for hemodialysis, peritoneal dialysis, or hemofiltration
• moderate or severe liver disease
• known human immunodeficiency virus infection
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Fosmanogepix IV infusion, Drug: Fosmanogepix oral tablet, Drug: Standard of care antifungal therapy
Conditions:
Infectious Diseases
Keywords:
Invasive Mold Infections, Mold
Study Contact: Natalie Eichten - eicht024@umn.edu
Principal Investigator: Jo-Anne Young, MD
Phase: PHASE3
IRB Number: STUDY00025966
See this study on ClinicalTrials.gov