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

2 1 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Salamanca Salamanca Spain
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Institut Jules Bordet Anderlecht Belgium
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Hospital Clinic De Barcelona Barcelona Spain
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hopital Beaujon Clichy France
Hqnumyig Vxeq dbzbslvb Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.03.2026
France France
Recruiting
01.03.2026
Italy Italy
Recruiting
01.03.2026
Spain Spain
Recruiting
01.03.2026

Trial locations

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.

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 ID:
2025-522835-32-00
Protocol code:
EL219.IV.2.04
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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

    Recruiting

    3 1 1 1
    Austria Belgium France Germany Greece Italy +2
  • Study on Fluconazole for Children and Adolescents with Fungal Infections

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands