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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hopital Necker Enfants Malades Paris France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Tenon Paris France
CHU Gabriel-Montpied Clermont Ferrand France
Hospital Edouard Herriot Lyon France
Centre Hospitalier Universitaire d’Orléans Orléans France
Hopital Ambroise Pare Boulogne-Billancourt France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospital Region Metz Thionville Metz France
Cameaa Hyrcvpytveu Ufhaywkzcwcdt Dd Duarp Dijon France
Arrtcewfaq Pgtcwplx Hwwnmqvd Dq Pyjqh Paris France
Cgda Du Nvpxi Vandoeuvre Les Nancy France
Ghgygr Hmujzhjvklb Uqvaikcaupvdo Plchg Puptsegnznk Ev Noconjpodaye Paris France
Ctngwr Hvvzqlippcd Rciouysv Dtzgscpmzkvfiw Angers France
Inhqtjdr Pebbpfjvkrqohav Cdtglu Cqjyvr Marseille France
Hziyivsn Ufiahdomnquahv Sgimxzwbkw &kxwpdl Hdpnpyc dq Hbxwflozwlb STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
18.02.2021

Trial locations

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.

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 ID:
2024-514344-82-00
Protocol code:
APHP180584
NCT ID:
NCT04680884
Trial Phase:
Therapeutic confirmatory (Phase III)

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