Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

EFRAIM II _ Empirical steroids and/or antifungals in immunocompromised patients with acute respiratory failure from undetermined etiology: a multicenter double-blind randomized controlled trial

This medical study, called EFRAIM II, is for adult patients who are in intensive care with severe breathing difficulties, and doctors aren't sure what's causing it. We're testing if giving certain steroids (like methylprednisolone) or anti-fungal medicines (like Cresemba) can improve their chances of getting better. Some patients will receive one of these medicines, some will receive both, and others will receive a dummy treatment (placebo) to see which approach is most effective. We are carefully checking how many patients are alive after 90 days, as well as looking at other important details like how long they stay in intensive care, if they get any infections, and their overall quality of life much later on. This is a crucial step to find better treatments for very unwell patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

420

Start

19 Jul 2024

patients with acute respiratory failure from undetermined etiology

What is this study about?

Imagine you or someone you know is very sick in the intensive care unit (ICU) because they're struggling to breathe, and doctors aren't quite sure why. This can be a very worrying time, and medical teams are always looking for the best ways to help. This study, called EFRAIM II, is designed to investigate if certain medications can make a real difference for these specific patients.

We know that some patients with severe breathing problems also have a weakened immune system, which can make them more vulnerable to infections or inflammation. In this study, we're focusing on two types of medicines: a steroid called methylprednisolone, which helps reduce inflammation, and an anti-fungal medicine called Cresemba, which treats certain fungal infections. By carefully comparing these treatments, alone or together, against a dummy treatment (placebo), we hope to learn which approaches are most effective in helping patients recover and improve their chances of survival.

Our main goal is to see how many patients are still alive 90 days after starting treatment. We'll also be looking at many other important things, like how long patients need to stay in intensive care, if they get any new infections, and how their general health and quality of life are doing months down the line. This research is a really important step towards finding better ways to care for very sick patients with unexplained breathing difficulties.

Key takeaways

This study investigates new treatments for severe breathing problems in intensive care.
It tests a steroid (methylprednisolone) and an anti-fungal medicine (Cresemba).
The primary aim is to see if treatments improve survival rates over 90 days.
Patients may receive active drugs or a dummy treatment (placebo).
Detailed health monitoring will occur during and after the hospital stay.
Participation is voluntary and can be withdrawn at any time.

Who may be eligible?

This study is looking for adults who are 18 years old or older. Both men and women can take part.

To be included, you must be in an intensive care unit (ICU) because you're having serious trouble breathing, and doctors haven't yet figured out the exact cause of your breathing problems.

There will also be other specific medical details that your doctors will check to make sure the study is a good fit for your situation. These detailed checks are important to ensure the study is safe and that we can get clear results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in an intensive care unit (ICU)?
Are you experiencing severe breathing problems?
Do doctors not yet know the exact cause of your breathing problems?

Answer every question to see your result.

What does participation involve?

If you or your loved one were to take part in this study, you would receive either methylprednisolone, Cresemba, both, or a dummy medicine (placebo) through a drip. The doctors and nurses caring for you would decide which treatment you receive as part of the study; neither you nor they would know if it's the active drug or placebo. You would continue to receive your usual medical care.

Throughout your stay in the intensive care unit and beyond, the study team would carefully monitor your health. This would involve regular checks of your vital signs, blood tests, and observations from your medical team. After you leave the intensive care unit and potentially the hospital, there would be follow-up checks at specific times to see how you are recovering. This might involve looking at your medical records and potentially asking you to complete some questionnaires about your health and how you are feeling at 3 and 6 months after starting the study. The total duration of active follow-up for the study would be around 6 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that one of the study medications might help you recover better from your severe breathing problems, potentially improving your chances of survival or reducing your time in intensive care. However, because we don't yet know if these treatments are better, there's also a possibility that the study medication may not help, or you might receive a placebo. All medications have potential side effects, and the study team will closely monitor you for any adverse reactions. You will always receive the best standard medical care regardless of whether you are in the study or not, and you are free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is the main goal of this study?

The main goal is to find out if certain steroids or anti-fungal medicines can improve survival for patients with severe, unexplained breathing problems in intensive care within 90 days.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers understand if the study medicine is truly effective.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study, neither you nor your doctors will know if you are receiving the active medicine or the placebo. This helps ensure the results are unbiased and reliable.

Who can take part in this study?

Adults aged 18 or over who are in intensive care with severe breathing problems whose cause is not yet known can be considered for the study. Your medical team will check if you meet all the specific criteria.

What happens if I want to stop taking part?

You are free to leave the study at any time, for any reason, without it affecting the care you receive from your doctors and nurses.