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Study on the Effectiveness and Safety of Olorofim vs. Liposomal Amphotericin B for Patients with Invasive Aspergillosis

Verified siteRegistered 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 a serious condition known as invasive aspergillosis, which is a type of fungal infection caused by the Aspergillus species. The study aims to evaluate the effectiveness and safety of two treatments for this infection. The first treatment being tested is a medication called Olorofim, which is taken in tablet form. The second treatment involves the use of AmBisome, a form of liposomal amphotericin B, which is administered through an infusion into the veins. The purpose of the study is to compare these two treatments to see which one is more effective and safer for patients with this type of fungal infection.

Participants in the study will be randomly assigned to receive either Olorofim or AmBisome followed by standard care. The study will last for a period of up to 91 days, during which the health and progress of the participants will be closely monitored. The study will assess various outcomes, including the overall response to the treatment and the survival rate of the participants. The study will also look at the quality of life of the participants during and after the treatment period.

This trial is designed to provide valuable information on the best treatment options for patients suffering from invasive aspergillosis. By comparing the two treatments, researchers hope to find the most effective way to manage this serious infection and improve patient outcomes. Participants will be under the care of medical professionals throughout the study to ensure their safety and well-being.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, weight, and medical condition related to invasive fungal infections caused by Aspergillus species.

    Participants must be able to comply with the study protocol and meet specific health and safety requirements.

  2. Step 2

    Initial treatment phase

    Participants are randomly assigned to receive either AmBisome or Olorofim as initial treatment.

    AmBisome is administered as a dispersion for infusion through intravenous use. The dosage and frequency are determined by the study protocol.

    Olorofim is provided in tablet form for oral use. The dosage and frequency are specified by the study protocol.

  3. Step 3

    Monitoring and assessment

    Participants undergo regular assessments to monitor the response to treatment. This includes clinical evaluations, radiological imaging, and laboratory tests.

    The primary focus is on the rate of all-cause mortality at Day 42, with additional assessments at Days 14, 28, 42, 84, and at the end of treatment (EOT).

  4. Step 4

    Follow-up phase

    After completing the treatment phase, participants enter a follow-up period to evaluate long-term outcomes and any potential secondary infections.

    Quality of life is assessed using a standardized questionnaire at baseline, Day 14, and EOT.

  5. Step 5

    Completion of the study

    The study concludes with a final evaluation of the participant's health status and overall response to the treatment.

    The estimated end date for the study is November 28, 2025.

Who can join the trial?

10 criteria

  • Patients must be male or female, at least 18 years old, and weigh at least 30 kg. If a patient cannot read or write, they must fully understand the information given by the study doctor.
  • Patients must have a confirmed or likely infection caused by a fungus called Aspergillus in any part of the body or in the lower lungs. The treatment for this infection should not have lasted more than 28 days.
  • Patients need treatment with an antifungal medicine that is not a type called azole. They should have had no more than 96 hours of previous treatment that might work against the infection. This includes:
    • Proven or suspected resistance to azole medicines.
    • Infection that occurred despite taking azole medicines to prevent it.
    • Any other medical reason why azole medicines are not suitable.
    • Infection that does not improve with azole treatment, with no more than 28 days of previous treatment.
    • The medicine AmBisome® must be suitable for the patient. Previous treatment with amphotericin B (like AmBisome®) is allowed if it follows the rules for treatment duration.
    • Patients must be able and willing to follow the study rules.
    • Female patients must not be breastfeeding and must not be at risk of becoming pregnant.
    • Male patients with female partners who can become pregnant must either not have sexual intercourse or use a very effective form of birth control.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of infection that is not caused by the Aspergillus fungus.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a severe allergic reaction to similar medications in the past.
  • Patients who have a history of substance abuse that could interfere with the study.
  • Patients who have a mental health condition that could affect their ability to participate in the study.
  • Patients who have a serious heart condition that could be worsened by the study medication.
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Investigated drugs

  • Olorofim

    is a medication being studied for its effectiveness and safety in treating invasive fungal disease caused by Aspergillus species. It is being compared to other treatments to see if it can help patients recover from these serious infections.

  • AmBisome

    is a medication used in the trial as a treatment for invasive fungal disease. It is often used as an initial treatment before switching to other standard care options. The trial aims to see how well it works compared to olorofim in treating infections caused by Aspergillus species.

What is already known about the treatment

  • Olorofim

    Olorofim is administered orally and is currently being studied in clinical trials for its effectiveness against invasive fungal infections caused by Aspergillus species. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for olorofim is the treatment of invasive fungal disease, particularly in cases where traditional treatments may not be effective. At the molecular level, olorofim works by inhibiting an enzyme essential for the synthesis of fungal cell walls, thereby preventing the growth and spread of the fungus. It is classified pharmacologically as an antifungal agent.

  • AmBisome

    AmBisome is administered intravenously and is an established medication used in the treatment of serious fungal infections, including those caused by Aspergillus species. It is widely recognized in medical literature and is part of the standard of care for invasive fungal diseases. The main therapeutic indication for AmBisome is the treatment of severe fungal infections, particularly in immunocompromised patients. Its mechanism of action involves binding to fungal cell membranes, causing them to become porous and leading to cell death. AmBisome is classified as an antifungal medication, specifically a liposomal formulation of amphotericin B.

Investigated diseases

Invasive Aspergillosis – This is a serious infection caused by the Aspergillus fungus, which is commonly found in the environment. It primarily affects individuals with weakened immune systems, such as those undergoing chemotherapy or organ transplants. The infection typically begins in the lungs, as the spores are inhaled, and can spread to other parts of the body, including the brain, heart, and kidneys. Symptoms may include fever, cough, chest pain, and difficulty breathing. As the disease progresses, it can lead to severe respiratory issues and other complications. Early detection and management are crucial to prevent further spread and damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513030-38-00Protocol codeF901318/0041Estimated enrolment225 patientsSponsorF2G Limited

sourced from the EU Clinical Trials Register and site verification

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