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Tests treatment safety and results for Invasive Mold Infections
Official title A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
ClinicalTrials.gov ID: NCT06925321
What this study is testing
What is Fosmanogepix IV infusion?
Fosmanogepix IV infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for invasive mold infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of...
- Patient's condition allows for appropriate infection source control measures. Main Exclusion Critera:
- Refractory hematologic malignancy.
- Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
See the full eligibility criteria
- Main
- 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...
- Patient's condition allows for appropriate infection source control measures. Main Exclusion Critera:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Hollywood, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Clayton, Australia
- Melbourne, Australia
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Hollywood, Florida, United States; Chicago, Illinois, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.