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Study on the Effectiveness and Safety of Fosmanogepix Compared to Caspofungin and Fluconazole for Adults with Candidemia or Invasive Candidiasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of two serious fungal infections: candidemia and invasive candidiasis. These infections are caused by a type of yeast called Candida, which can enter the bloodstream and spread to other parts of the body, leading to severe health issues. The study will compare the effectiveness and safety of a new treatment called fosmanogepix, which is given first through an IV (intravenous) and then as an oral medication, against a standard treatment that starts with an IV of caspofungin followed by oral fluconazole.

The purpose of the study is to evaluate how well the new treatment works in adults with these infections. Participants will receive either the new treatment or the standard treatment, and some may receive a placebo. The study will monitor participants over a period to see how their infections respond to the treatments. This includes checking for improvements in symptoms and any side effects that may occur. The study aims to provide valuable information on whether the new treatment is a better option for managing these infections.

Participants will be closely monitored by healthcare professionals throughout the study. The study will involve regular check-ups and tests to track the progress of the treatment and ensure the safety of all participants. The results of this study could help improve treatment options for people suffering from these serious fungal infections in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide signed informed consent. This indicates that you understand the purpose and procedures required for the study and are willing to participate.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to confirm the diagnosis of candidemia and/or invasive candidiasis. This includes tests to detect the presence of Candida in your blood or from a sterile site.

    The assessment will also check for symptoms such as fever, low body temperature, low blood pressure, rapid breathing, rapid heart rate, and local signs of infection.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two treatment groups. One group will receive IV fosmanogepix followed by oral fosmanogepix, and the other group will receive IV caspofungin followed by oral fluconazole.

  4. Step 4

    Treatment phase

    During the treatment phase, you will receive the assigned medication. The initial phase involves intravenous (IV) administration, followed by oral medication.

    The duration and dosage of the medication will be determined by the study protocol and your healthcare provider.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular blood tests, clinical assessments, and possibly other diagnostic tests.

    You will be evaluated for treatment success and any side effects. The study will also track the time it takes for your blood cultures to become negative.

  6. Step 6

    End of study treatment

    At the end of the study treatment (EOST), your overall response to the treatment will be assessed by an independent committee.

    You will continue to be monitored for a period after the treatment to evaluate long-term outcomes and any delayed side effects.

Who can join the trial?

6 criteria

  • Patients must be 18 years or older at the time of screening. If the country requires a higher age for consent, that age applies.
  • Patients must provide signed informed consent, which means they understand the study's purpose and procedures and agree to participate.
  • Patients must have a diagnosis of candidemia and/or invasive candidiasis within the last 96 hours (4 days) before being randomly assigned to a treatment group. This means:
    • There is a positive test for yeast or Candida in the blood or from a normally sterile area of the body.
    • A positive result from a rapid diagnostic test for Candida from a blood sample.
    • Presence of clinical signs like fever (high body temperature), hypothermia (low body temperature), hypotension (low blood pressure), tachypnea (fast breathing), tachycardia (fast heart rate), or local signs of infection such as swelling or redness.
    • The patient's condition must allow for infection source control measures, such as removing any pre-existing catheters or devices if needed.

Who cannot join the trial?

7 criteria

  • Patients who have a known allergy or severe reaction to the study drugs cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of certain serious medical conditions that might interfere with the study cannot join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients who have received certain medications that might interfere with the study drugs are excluded.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures cannot participate.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study are not eligible.
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Investigated drugs

  • Fosmanogepix

    is a medication being tested in this clinical trial. It is given first through an IV, which means it is delivered directly into your bloodstream through a vein. After the initial IV treatment, it is taken by mouth as a pill. This medication is being studied to see how well it works in treating infections caused by a type of fungus, specifically in conditions known as candidemia and invasive candidiasis. These are serious infections that can occur in the blood or other parts of the body.

  • Caspofungin

    is a medication used as a standard treatment for fungal infections. In this trial, it is given through an IV, which means it is administered directly into the bloodstream. Caspofungin is used to treat serious fungal infections, and in this study, it serves as a comparison to see how well the new medication, fosmanogepix, works.

  • Fluconazole

    is another medication used in this trial as part of the standard treatment for fungal infections. After the initial treatment with caspofungin, fluconazole is taken by mouth as a pill. It is commonly used to treat and prevent various fungal infections, and in this study, it helps to compare the effectiveness of the new treatment being tested.

What is already known about the treatment

  • Fosmanogepix

    Fosmanogepix is administered initially through an intravenous (IV) infusion and then followed by oral tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating invasive candidiasis and candidemia, which are serious fungal infections. The medication works by targeting and inhibiting a specific enzyme in the fungal cells, which is crucial for their survival and growth. Fosmanogepix belongs to a class of antifungal agents that are designed to combat fungal infections by disrupting their cellular processes.

  • Caspofungin

    Caspofungin is given through an intravenous (IV) infusion and is part of the standard treatment for invasive candidiasis and candidemia. It is well-established in medical practice and literature as an effective antifungal medication. Caspofungin works by inhibiting the synthesis of a vital component of the fungal cell wall, leading to the death of the fungal cells. It is classified as an echinocandin, a type of antifungal drug that targets the cell wall of fungi.

  • Fluconazole

    Fluconazole is administered orally in tablet form and is commonly used in the treatment of invasive candidiasis and candidemia. It is a well-known antifungal medication with extensive use in medical practice. Fluconazole functions by interfering with the production of a key component of the fungal cell membrane, thereby inhibiting the growth and replication of the fungus. It is classified as an azole antifungal, which targets the cell membrane of fungi.

Investigated diseases

  • Invasive candidiasis

    Invasive candidiasis is a severe fungal infection caused by Candida species that enter the bloodstream and spread throughout the body. It can affect various organs, including the heart, brain, eyes, bones, and other tissues. The disease often begins with a fever and chills that do not improve with antibiotic treatment. As the infection progresses, it can lead to organ dysfunction and other systemic symptoms. The condition is more common in individuals with weakened immune systems or those with medical devices like catheters. It requires prompt medical attention to prevent further complications.

  • Candidemia

    Candidemia is a bloodstream infection caused by Candida species, a type of yeast. It is the most common form of invasive candidiasis and can lead to serious health issues if not addressed. The infection typically presents with symptoms such as fever, chills, and fatigue, which may persist despite antibiotic treatment. As the yeast circulates in the bloodstream, it can spread to other parts of the body, potentially affecting organs and tissues. Candidemia is often associated with hospital settings, particularly in patients with compromised immune systems or those undergoing invasive procedures. Early detection and management are crucial to control the spread of the infection.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500455-23-00Protocol codeFMGX-CS-301Estimated enrolment436 patientsSponsorBasilea Pharmaceutica International AG Allschwil

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).