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A study to compare the effectiveness of EL219 against liposomal amphotericin B and voriconazole for patients with suspected invasive mould infections.

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What is this trial about?

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

This study is being conducted to evaluate the safety and effectiveness of a new medication called EL219 compared to the current standard treatment for patients with a suspected Invasive Mould Infection. An invasive mould infection occurs when certain types of fungi, which are microscopic organisms, grow deep inside the body and cause serious illness. The current standard treatment involves using Amphotericin B, Liposome through an intravenous line, which is a tube placed in a vein to deliver fluids directly into the bloodstream, followed by a medication called Voriconazole taken by mouth.

During the study, participants will be assigned to receive either the new experimental drug EL219 or the standard medications. To ensure the results are unbiased, a double-blind method is used, meaning neither the patients nor the medical staff know which specific treatment is being administered. In this process, some participants may receive a placebo, which is an inactive substance used for comparison. The course of the study involves monitoring the participants over a period of time to see how they respond to the treatments and to track any side effects.

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

    Treatment assignment

    You will be assigned to one of two different treatment paths to manage a suspected invasive mould infection, which is a serious fungal infection.

    The assignment is made using a randomized process, meaning it is determined by chance, and the study is double-blind, so neither you nor the medical staff will know which specific medication is being administered during the treatment phase.

  2. Step 2

    Treatment path 1: experimental therapy

    You will receive EL219, which is an experimental antifungal medication used to treat fungal infections.

    This medication is given as a solution for infusion through an intravenous line, which means it is delivered directly into a vein.

  3. Step 3

    Treatment path 2: standard care

    You will receive a combination of two medications as the current standard of care.

    First, you will receive amphotericin B, liposome through an intravenous infusion at a dose of 3 mg/kg (milligrams per kilogram of body weight).

    This may be followed by voriconazole, which is administered via intravenous infusion at a dose of 12 mg/kg.

  4. Step 4

    Transition to oral medication

    After the initial intravenous treatment phase, the treatment may transition to oral voriconazole.

    This medication is taken in the form of a hard capsule at a dose of 8 mg/kg.

  5. Step 5

    Monitoring and evaluation

    Your response to the treatment will be monitored closely to evaluate safety and effectiveness.

    The effectiveness of the therapy is assessed at day 42 by checking for survival and improvements in clinical, fungal, and imaging results.

    Safety monitoring includes looking for adverse events, which are unexpected side effects, specifically focusing on the kidneys, electrolytes, liver, reactions to the infusion, and sensitivity to light.

Who can join the trial?

8 criteria

  • You must be a male or female who is 18 years of age or older.
  • You must be at risk for an invasive fungal infection, which is a serious infection caused by fungi (such as mold) that has spread into the body's deep tissues.
  • Risk factors include having received an allogeneic bone marrow transplant, which means receiving stem cells (cells that can develop into different types of blood cells) from a donor.
  • Risk factors include currently receiving or having recently received (within the last month) cytotoxic, biological, or immunomodulatory treatments. These are medicines used to treat malignant hematological tumors, which are cancers of the blood or bone marrow.
  • Risk factors include using corticosteroids, which are a type of steroid medicine used to reduce inflammation, at a dose of at least 0.3 mg/kg/day of prednisone equivalent for more than 3 weeks.
  • Risk factors include using other immunosuppressants, which are medications that weaken the body's immune system (the body's natural defense against germs), such as cyclosporine or TNF-alpha inhibitors, within the last 3 months.
  • You must have a suspected invasive mould infection, meaning doctors believe you may have a deep-seated infection caused by mold.
  • You must be willing to follow the specific dosing (how much medicine you take), the study visit schedule (when you need to come to the clinic), and the mandatory procedures (required medical tests or exams) described in the study plan.

Who cannot join the trial?

9 criteria

  • You cannot join if you have had a proven or probable invasive mould infection (an infection caused by fungus that has spread deep into the body) within the last month, or if you have an infection that has returned and did not respond to other treatments.
  • You cannot join if you have taken antifungal medication (medicine used to treat fungus infections) for more than 96 hours before starting the study, or if you will need to use other types of fungus medicine during the study period.
  • You cannot join if you were diagnosed with a systemic bacterial infection (a bacterial infection that has spread throughout the entire body) in the 14 days before joining the study.
  • You cannot join if your blood tests show high levels of alanine aminotransferase (ALT) or total serum bilirubin, which are markers used to check how well your liver is working.
  • You cannot join if your blood tests show high serum creatinine or low creatinine clearance, which are measurements used to check how well your kidneys are filtering your blood.
  • You cannot join if you have cirrhosis of the liver (permanent scarring of the liver), symptomatic heart failure (a condition where the heart cannot pump enough blood to meet the body's needs), or reduced lung function (difficulty breathing or lungs not working properly).
  • You cannot join if you are currently undergoing hemodialysis or peritoneal dialysis (treatments used to clean the blood when the kidneys are not working).
  • You cannot join if you or a family member has a history of long QT interval syndrome, which is a specific change in the electrical activity of the heart measured by an ECG (a test that records the heart's electrical signals).
  • You cannot join if you have previously received an orthotopic lung transplant (a surgical procedure to replace a diseased lung with a healthy donor lung).
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Investigated drugs

  • EL219

    is an experimental medication given through a vein to treat serious infections caused by moulds.

  • Amphotericin B

    is a medication given through a vein used as a standard treatment to fight serious fungal infections.

  • Voriconazole

    is an antifungal medication that can be given through a vein or taken by mouth to treat infections caused by certain types of fungi or moulds.

What is already known about the treatment

  • Amphotericin B, Liposome

    This medication is an antifungal drug administered through an intravenous infusion to treat serious fungal infections. It is a well-established treatment in medicine that works by attaching to specific components in the fungal cell membrane, creating holes that cause the fungal cells to leak and die. Classified as a polyene antifungal, it is commonly used for severe or life-threatening mold and yeast infections.

  • Voriconazole

    This is an antifungal medication that can be taken either as an oral capsule or through an intravenous injection. It is a widely used treatment for various invasive fungal infections and works by blocking a specific enzyme that fungi need to build their protective cell walls. As a member of the triazole class of antifungals, it prevents the fungus from growing and spreading within the body.

  • EL219

    This is an experimental antifungal substance currently being studied in clinical trials and is administered via intravenous infusion. It is designed to treat suspected invasive mold infections by targeting and disrupting the cell membranes of the fungi. This medication belongs to a class of advanced antifungal agents being developed to provide effective treatment with potentially improved safety profiles.

Investigated diseases

Invasive mould infection - This condition occurs when certain types of fungi, known as moulds, enter and spread through the body's tissues. These fungi often target internal organs, such as the lungs. The infection can begin as a localized issue and then move into the bloodstream or surrounding tissues. As the infection progresses, it can cause damage to various organ systems. The severity of the condition often depends on how quickly the mould spreads within the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522835-32-00Protocol codeEL219.IV.2.04Estimated enrolment60 patientsSponsorElion Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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