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Anti-fungal agent

Fosmanogepix for Candida Blood Infection

Phase 3

Recruiting

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:

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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.

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I have been diagnosed with a deep fungal infection.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

0 / 7Eligibility criteria met