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Study on the Effects of Methylprednisolone and Isavuconazonium Sulfate in Immunocompromised Patients with Acute Respiratory Failure of Unknown Cause

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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 treatments for patients who are immunocompromised and experiencing acute respiratory failure of unknown origin. Being immunocompromised means that a person's immune system is weakened, which can happen due to conditions like cancer or after receiving an organ transplant. The study will explore the effects of using steroids and/or antifungal medications to help these patients. Specifically, the trial will use a steroid called METHYLPREDNISOLONE and an antifungal medication called CRESEMBA (also known as isavuconazonium sulfate).

The purpose of the study is to see if these treatments can reduce the risk of death within 90 days for patients with acute respiratory failure. Participants in the study will receive either the medications or a placebo, which is a substance with no active ingredients, for up to 14 days or until they are discharged from the intensive care unit (ICU). The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, researchers will monitor various outcomes, including survival rates at different time points, the occurrence of infections, and the overall quality of life of the participants. The goal is to gather information that could lead to better treatment strategies for immunocompromised patients facing severe respiratory issues.

The research process

The trial runs in 4 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, the patient must meet specific criteria, including being between 18 and 90 years old, having a condition that requires immunosuppressive treatment, and experiencing acute respiratory failure without a known cause.

    The patient must have been admitted to the hospital for at least 24 hours and have signed an informed consent form, either personally or through a representative if unable to do so.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of methylprednisolone and/or isavuconazonium sulfate (CRESEMBA) through intravenous infusion.

    The treatment is designed to last for 14 days or until the patient is discharged from the intensive care unit (ICU).

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment period, the patient's health will be closely monitored to assess the effectiveness of the medication in reducing mortality and managing symptoms.

    The primary goal is to reduce mortality by day 90, with additional evaluations of ICU mortality, hospital mortality, and other health outcomes.

  4. Step 4

    Follow-up assessments

    After the treatment period, follow-up assessments will be conducted to monitor the patient's health status, including the occurrence of any infections or complications.

    The study will also evaluate the patient's quality of life and mental health at six months, using standardized questionnaires.

Who can join the trial?

15 criteria

  • Must be between 18 and 90 years old.
  • Must have a condition that affects the immune system, such as:
    • Taking drugs that weaken the immune system (immunosuppressive drugs).
    • Having had a solid organ transplant.
    • Having a solid tumor, which is a type of cancer.
    • Having blood-related cancers (hematological malignancies).
    • Having a primary immune deficiency, which means the immune system is not working properly from birth.
    • Must be admitted to the Intensive Care Unit (ICU) for **acute respiratory failure**, which means having trouble breathing, shown by:
      • Breathing very fast (more than 30 breaths per minute).
      • Having a bluish color to the skin (cyanosis), which means not enough oxygen in the blood.
      • Having difficulty breathing.
      • Needing more than 6 liters of standard oxygen to keep oxygen levels in the blood above 95%, or needing high-flow oxygen, or machines to help with breathing (non-invasive or invasive mechanical ventilation).
      • The cause of the acute respiratory failure must not be known 24 hours after being admitted to the hospital.
      • Must have been in the hospital for at least 24 hours.
      • Must have signed an informed consent form, which means agreeing to participate in the study:
        • Either signed by the patient themselves.
        • Or signed by a family member or a trusted person if the patient is unable to sign due to their condition.
        • Or, in urgent situations where no family member or trusted person is available, the patient can be enrolled, and consent will be requested as soon as the patient is able to provide it.

Who cannot join the trial?

5 criteria

  • Patients who do not have acute respiratory failure from an unknown cause cannot participate. Acute respiratory failure means the lungs are not working well enough to get oxygen into the blood or remove carbon dioxide from the blood.
  • Patients who are not immunocompromised cannot participate. Being immunocompromised means having a weakened immune system, which makes it harder for the body to fight infections and diseases.
  • Patients who are not within the specified age range cannot participate. The age range includes certain age groups, but the specific ages are not listed here.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.
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Investigated drugs

  • Steroids

    are medications used to reduce inflammation in the body. In this trial, they are being used to help decrease inflammation in the lungs of immunocompromised patients who are experiencing acute respiratory failure. The goal is to see if reducing inflammation can improve survival rates.

  • Isavuconazole

    is an antifungal medication. It is used to treat fungal infections, which can be a risk for immunocompromised patients. In this trial, isavuconazole is being tested to see if it can help improve outcomes for patients with acute respiratory failure by preventing or treating potential fungal infections.

What is already known about the treatment

  • Isavuconazole

    Isavuconazole is administered orally or intravenously and is used to treat fungal infections. It is currently recognized in medical literature as an antifungal medication, particularly for patients with compromised immune systems. The main therapeutic indication for isavuconazole is the treatment of invasive fungal infections, such as aspergillosis and mucormycosis. At the molecular level, isavuconazole works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, thereby disrupting cell membrane formation and function. It is classified pharmacologically as an azole antifungal agent.

  • Empirical Steroids

    Empirical steroids are typically administered orally or intravenously and are used to reduce inflammation in various medical conditions. In the context of the clinical trial, they are being evaluated for their potential to reduce mortality in immunocompromised patients with acute respiratory failure of unknown cause. The mechanism of action involves modulating the immune response and decreasing inflammation by inhibiting the production of inflammatory mediators. Steroids are classified as anti-inflammatory and immunosuppressive agents.

Investigated diseases

Acute Respiratory Failure – This condition occurs when the lungs cannot provide enough oxygen to the blood or remove carbon dioxide from the blood. It can develop suddenly or gradually and may be caused by various factors, including infections, injuries, or chronic lung diseases. Symptoms often include difficulty breathing, rapid breathing, and confusion. The progression of acute respiratory failure can lead to severe complications if not addressed promptly. It requires immediate medical attention to stabilize the patient's breathing and address the underlying cause.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514344-82-00Protocol codeAPHP180584Estimated enrolment420 patientsSponsorAssistance Publique Hopitaux De Paris

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