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Anti-fungal agent
Fosmanogepix for Candida Blood Infection
Phase 3
Waitlist Available
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Female patient is pregnant or lactating.
Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Pivotal Trial
Summary
This trial is testing a new medicine called Fosmanogepix for the treatment of a serious fungal infection called candidemia and/or invasive candidiasis caused by yeast. Patients with this infection are
Who is the study for?
This trial is for adults diagnosed with candidemia or invasive candidiasis who understand the study and agree to participate. They must have had a diagnosis within 4 days before joining the trial and be able to undergo necessary procedures like removing catheters if needed.
What is being tested?
The trial tests Fosmanogepix, comparing it against standard treatments Caspofungin/Fluconazole for fungal infections caused by Candida. Patients will receive either IV infusions followed by oral tablets of the study drug or standard care, aiming to prove Fosmanogepix is at least as effective.
What are the potential side effects?
Potential side effects are not explicitly listed in this summary but may include reactions typical of antifungal medications such as nausea, rash, liver enzyme changes, kidney issues, and infusion-related reactions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
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I am allergic to fosmanogepix, manogepix, caspofungin, echinocandins, fluconazole, or their ingredients.
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I cannot control my fungal infection through usual methods.
Select...
I have been diagnosed with a deep fungal infection.
Select...
I have a history of neurological disorders.
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I need or will likely need dialysis.
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I am not taking any medication that is not allowed in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fosmanogepix IV/oralExperimental Treatment2 Interventions
Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth.
Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).
Group II: Caspofungin IV/ Fluconazole oralActive Control3 Interventions
Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth.
Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Basilea PharmaceuticaLead Sponsor
51 Previous Clinical Trials
9,457 Total Patients Enrolled
3 Trials studying Candidemia
480 Patients Enrolled for Candidemia
PfizerLead Sponsor
4,650 Previous Clinical Trials
17,743,213 Total Patients Enrolled
15 Trials studying Candidemia
2,954 Patients Enrolled for Candidemia
Manuel Häckl, MDStudy DirectorBasilea Pharmaceutica International Ltd, Allschwil
4 Previous Clinical Trials
290 Total Patients Enrolled
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