Study of fosmanogepix compared to standard antifungal drugs for treating invasive mold infections in adults

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What is this study about?

This study focuses on treating invasive mold infections caused by various types of fungi, including Aspergillus, Fusarium, Lomentospora prolificans, and Mucorales fungi. The main treatment being tested is fosmanogepix, which will be given both as an infusion into a vein and as tablets by mouth. The study will compare fosmanogepix with other antifungal medications including voriconazole, anidulafungin, amphotericin B, rezafungin, micafungin, caspofungin, isavuconazole, posaconazole, and terbinafine.

The purpose of this research is to evaluate how well fosmanogepix works and how safe it is for treating adults who have serious fungal infections. The study will look at whether the treatment helps patients survive and recover from their infections. The treatment period can last up to 180 days, depending on how each patient responds.

During the study, doctors will monitor patients’ progress through various tests and examinations. They will check how well the infection responds to treatment by looking at clinical symptoms, laboratory tests, and imaging scans. They will also carefully track any side effects that may occur during treatment.

1 Initial treatment phase

You will receive fosmanogepix through an intravenous (IV) infusion, which means the medication will be given directly into your vein

The IV infusion will last 3 hours

Blood samples will be collected before the infusion and at 3, 6, and 9 hours after the start of the infusion on day 3

A final blood sample will be taken at 24 hours, before the day 4 dose

2 Transition to oral medication

Starting from day 7, you will begin taking fosmanogepix tablets by mouth

Blood samples will be collected on days 7, 14, 28, and 42 to measure medication levels

3 Monitoring and evaluation period

Your response to treatment will be evaluated on day 42 and day 84

Doctors will assess your clinical condition, perform laboratory tests, and take images to check your progress

Regular examinations will include heart monitoring (ECG) and neurological checks

Any side effects will be recorded throughout the treatment period

4 Final assessment

After completing treatment, you will have a follow-up period lasting 6 weeks

Final blood samples will be collected 72 hours (±1 day) and 192 hours (±2 days) after your last dose

The total duration of your participation may be up to 8 months

Who Can Join the Study?

  • Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of invasive mold infection (a serious fungal infection that has spread inside the body) caused by specific types of fungi:
    • Aspergillus species (in patients with limited treatment options)
    • Fusarium species
    • Lomentospora prolificans
    • Mucorales fungi
    • Other molds that are resistant to multiple medications
  • The infection must be either:
    • Proven (confirmed through laboratory tests)
    • Probable (highly likely based on medical evidence)
  • Must be in a condition that allows doctors to properly treat the source of the infection
  • Both men and women may participate in the study

Who Cannot Join the Study?

  • Age below 18 years
  • Pregnancy or breastfeeding
  • Known severe allergic reactions to medications similar to the study drug
  • Severe liver problems (as determined by blood tests)
  • Severe kidney problems requiring dialysis (a procedure to filter blood when kidneys don’t work properly)
  • Active cancer treatment that might interfere with the study medication
  • Taking other medications that could interact with the study drug
  • Unable to take oral medications
  • Participation in another clinical trial within the past 30 days
  • Having any condition that, in the opinion of the study doctor, would make participation unsafe
  • History of aspergillosis (fungal infection) that is resistant to all available treatments
  • Severe heart conditions or unstable heart disease
  • History of organ transplantation
  • Active or chronic hepatitis B or C infection
  • Known HIV infection with inadequate immune system function

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Del Mar Barcelona Spain
Grand Hopital De Charleroi Charleroi Belgium
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Evangelismos S.A. Athens Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario De Cruces Barakaldo Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Kepler Universitaetsklinikum GmbH Linz Austria
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Lznbw Gadsjue Hgispjlt Ou Aujgmt Athens Greece
Utajegtlnq Hyieejyg Cklewlh Cologne Germany
Egysufs Uyeighzmijgb Mblujuz Cgruvva Rdbebngtu (odzkiiz Msx Rotterdam The Netherlands
Gtggsw Umcyjqenvr Fmeekqwor Frankfurt Germany
Hkhfwhek Dp Ld Swvzl Cfse I Sfqv Pcu Barcelona Spain
Hvdsiyeq Vwow dowglogr Barcelona Spain
Hkspodxx Uwzsjtyhkqvjuj Sszblohdgn &orjomx Hkksovz dh Hvuarvnnzfw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
06.09.2025
Belgium Belgium
Recruiting
06.09.2025
France France
Not yet recruiting
06.09.2025
Germany Germany
Not yet recruiting
06.09.2025
Greece Greece
Recruiting
06.09.2025
Italy Italy
Recruiting
06.09.2025
Spain Spain
Recruiting
06.09.2025
The Netherlands The Netherlands
Recruiting
06.09.2025

Trial locations

Fosmanogepix is an antifungal medication being studied for treating serious fungal infections. It works against various types of mold infections that can be difficult to treat with other medications. This new drug is specifically designed to fight against invasive infections caused by different types of molds, including Aspergillus, Fusarium, and other resistant fungi. It may provide a treatment option for patients who have limited choices due to drug resistance or who haven’t responded well to other antifungal treatments.

Invasive Mold Infection (IMI) – A serious fungal infection that occurs when certain types of molds invade deep tissues or organs in the body. The infection typically begins when a person inhales microscopic mold spores, which then spread beyond the respiratory system. Common causative molds include Aspergillus species, Fusarium species, Lomentospora prolificans, and Mucorales fungi. The infection can affect multiple organs and typically develops more frequently in people with weakened immune systems. The condition progresses by spreading through blood vessels and tissues, causing damage to affected organs.

Aspergillosis – A fungal infection caused by Aspergillus mold species that commonly starts in the respiratory system. The fungus can grow and spread within the lungs, forming masses of fungal fibers and inflammatory cells. In some cases, the infection can spread beyond the lungs to other parts of the body. The condition typically develops gradually, with symptoms becoming more noticeable as the infection progresses.

Fusariosis – An infection caused by Fusarium fungi that can affect various parts of the body. The infection commonly enters through damaged skin or through inhalation. Fusarium can spread throughout the body through the bloodstream. The infection may start on the skin or in the respiratory system before potentially spreading to other organs.

Mucormycosis – An infection caused by fungi of the Mucorales order that typically begins in the sinuses or lungs. The fungi can spread rapidly through blood vessels, causing tissue death in infected areas. The infection can progress to nearby structures including the eyes and brain. The condition develops relatively quickly compared to other fungal infections.

Trial ID:
2024-516216-16-00
Protocol code:
FMGX-CS-302
Trial Phase:
Therapeutic confirmatory (Phase III)

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