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A phase 3 efficacy and safety study of fosmanogepix for the treatment of adult patients with invasive mold infections
EU CTIS ID: 2024-516216-16-00
What this study is testing
To evaluate the efficacy of fosmanogepix for the treatment of adult patients with Invasive mold infections (IMIs) caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Diagnosis of proven or probable 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.
- 2. Patient’s condition allows for appropriate infection source control measures.
You likely can't join if
- 1. Refractory hematologic malignancy.
- 10. Other medical or psychiatric condition.
- 11. Current use of any prohibited concomitant medication(s).
- 12. Current/previous administration of an investigational drug within 30 days.
- 13. Prior enrollment in this or any previous study of fosmanogepix.
- 14. Moderate or severe hepatic impairment.
See the full eligibility criteria
- 1. Diagnosis of proven or probable 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.
- 2. Patient’s condition allows for appropriate infection source control measures.
- 1. Refractory hematologic malignancy.
- 10. Other medical or psychiatric condition.
- 11. Current use of any prohibited concomitant medication(s).
- 12. Current/previous administration of an investigational drug within 30 days.
- 13. Prior enrollment in this or any previous study of fosmanogepix.
- 14. Moderate or severe hepatic impairment.
- 15. Patient who is pregnant or lactating.
- 16. Known hypersensitivity to fosmanogepix, manogepix, or any of the excipients.
- 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- 3. Coronavirus disease 2019 (COVID-19) associated mucormycosis.
- 4. Invasive fungal disease caused by more than one fungal pathogen are not permitted in Cohort A but are permitted in Cohort B.
- 5. Patients with a Karnofsky Performance Status < 20 at Screening.
- 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
- 7. Patients with known human immunodeficiency virus infection.
- 8. Ongoing neurological disorders.
- 9. Patients receiving hospice/comfort care only.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Thailand
- Australia
- Canada
- Brazil
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Thailand; Australia; Canada; Brazil; United States. 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 EU CTIS; the study team decides eligibility.