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Study Comparing Ibrexafungerp and Fluconazole for Treating Candidemia or Invasive Candidiasis in Patients

Fast replyRegistered drugNo placebo
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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 Invasive Candidiasis and Candidemia, which are serious infections caused by a type of yeast called Candida. The study aims to compare two treatment regimens. The first regimen involves using an intravenous medication called echinocandin, followed by an oral medication named Ibrexafungerp (also known by its code name, SCY-078). The second regimen also starts with intravenous echinocandin but is followed by an oral medication called Fluconazole. A placebo, which looks like the real medication but does not contain the active ingredient, is also used in the study for comparison purposes.

The purpose of the study is to determine if the treatment with intravenous echinocandin followed by oral Ibrexafungerp is as effective as the treatment with intravenous echinocandin followed by oral Fluconazole. Participants in the study will receive one of these treatment regimens. The study will last for a period of up to six months, during which participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, participants will receive regular check-ups to assess their health and the effectiveness of the treatment. The study will help researchers understand which treatment regimen is more effective in treating Invasive Candidiasis and Candidemia, potentially leading to better treatment options for patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the initial treatment involves the administration of an intravenous medication known as echinocandin. This medication is used to treat infections caused by a type of fungus called Candida.

    The intravenous treatment is administered in a healthcare setting. The duration of this phase depends on the specific needs of the patient and the response to the treatment.

  2. Step 2

    Transition to oral medication

    After the initial intravenous treatment, the patient transitions to an oral medication. The study involves two possible oral medications: ibrexafungerp or fluconazole.

    The choice of oral medication is determined by the study protocol, and the patient will be randomly assigned to one of the two options.

  3. Step 3

    Oral medication regimen

    If assigned to ibrexafungerp, the patient will take this medication orally in tablet form. The specific dosage and frequency will be provided by the healthcare team.

    If assigned to fluconazole, the patient will take this medication orally in capsule form. The specific dosage and frequency will be provided by the healthcare team.

    The duration of the oral medication phase is determined by the patient's response to the treatment and the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health and response to the treatment are closely monitored. This includes regular check-ups and assessments by the healthcare team.

    The study aims to evaluate the effectiveness of the treatment regimens, focusing on the patient's recovery and any potential side effects.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall success of the treatment.

    The evaluation includes clinical assessments, laboratory tests, and any necessary imaging studies to ensure the infection has been effectively treated.

Who can join the trial?

2 criteria

  • The participant must be an adult, which means they are a male or female who is at least 18 years old on the day they sign the study consent form.
  • The participant must have a diagnosis of **candidemia** or **invasive candidiasis**. This means there is evidence of a type of yeast called **Candida** in their blood or in a tissue sample from a part of the body that is usually free of germs. This sample must be taken within 4 days of starting treatment with a medicine called **IV echinocandin**. The participant must also show any related signs or symptoms, such as a fever higher than 38°C, low blood pressure, or signs of inflammation in the area.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or severe reaction to the study medications cannot participate.
  • Individuals with a history of liver disease or liver problems may be excluded.
  • Patients who are currently taking medications that could interfere with the study drugs are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Individuals with a weakened immune system, such as those with HIV/AIDS, may be excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Individuals with a history of alcohol or drug abuse may be excluded from the study.
  • Patients with certain heart conditions or heart problems may not be able to participate.
  • Individuals who have had a recent surgery or are planning to have surgery soon may be excluded.
  • Patients with severe kidney disease or kidney problems may not be eligible.
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Investigated drugs

  • Echinocandin

    is a type of antifungal medication given through an intravenous (IV) infusion. It is used to treat serious fungal infections like candidemia and invasive candidiasis. In this trial, echinocandin is used as the initial treatment to help control the infection.

  • Ibrexafungerp

    is an oral antifungal medication that is used after the initial IV treatment with echinocandin. It is designed to continue fighting the fungal infection and prevent it from coming back. This medication is taken by mouth, making it easier for patients to continue their treatment outside of a hospital setting.

  • Fluconazole

    is another oral antifungal medication used in this trial. Like ibrexafungerp, it is taken after the initial IV treatment with echinocandin. Fluconazole helps to maintain control over the fungal infection and is a well-known treatment option for candidemia and invasive candidiasis.

What is already known about the treatment

  • Ibrexafungerp

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating invasive candidiasis and candidemia. It is a newer antifungal agent that works by inhibiting the synthesis of a key component of the fungal cell wall, leading to cell death. Ibrexafungerp is classified as a triterpenoid antifungal and is being compared to established treatments to determine its efficacy and safety.

  • Fluconazole

    This medication is taken orally and is widely used in the medical field for treating fungal infections, including invasive candidiasis and candidemia. It functions by inhibiting an enzyme necessary for the production of ergosterol, an essential component of the fungal cell membrane, thereby disrupting cell growth. Fluconazole is classified as an azole antifungal and is a well-established treatment option in clinical practice.

Investigated diseases

Invasive Candidiasis – This is a serious fungal infection caused by Candida species that can enter the bloodstream and spread throughout the body. It often affects people with weakened immune systems or those in hospital settings. The infection can lead to symptoms such as fever and chills that do not improve with antibiotics. As it progresses, it can affect various organs, including the heart, brain, eyes, and bones. The disease requires prompt medical attention to prevent further complications. It is distinct from superficial Candida infections, which affect the skin or mucous membranes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511755-18-00Protocol codeSCY-078-302Estimated enrolment240 patientsSponsorScynexis Inc.

sourced from the EU Clinical Trials Register and site verification

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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).