Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Inf… (NCT06433128) | Clinical Trial Compass
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Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections
Plain-language summary
The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an 'expanded access' program rather than a standard clinical trial, what does that mean for my situation — is it being offered because my invasive fungal infection hasn't responded to other antifungal treatments, or because approved options aren't available to me?
2Fosmanogepix works differently from many existing antifungals — can you explain what type of fungal infection I have and whether the evidence suggests this drug might be particularly relevant for it compared to what I'm currently receiving or could receive?
3Because expanded access programs collect safety data but aren't structured like a Phase 1, 2, or 3 trial, what is known so far about the side effects or risks of fosmanogepix, and how would we monitor for them if I joined?
4Are there any approved antifungal therapies — like echinocandins, azoles, or amphotericin-based drugs — that I haven't yet tried, and would it make sense to pursue those before considering expanded access to an investigational drug like fosmanogepix?
5What would participation actually involve day-to-day — would I need to be hospitalized, how often would I need check-ins or lab work, and is this something that fits realistically with my current condition and care setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.