AuthorisedTherapeutic confirmatory (Phase III)Interventional

ASPAPY - Aspirin in acute pneumonia in the elderly: a multicenter, double-blind, randomized, placebo-controlled trial

This research study, called ASPAPY, is investigating if aspirin can be a helpful treatment for older people who have severe pneumonia. Doctors want to understand if giving aspirin to these patients changes the number of deaths within 90 days of them joining the study. They are comparing aspirin to a 'dummy' treatment (placebo) to see any real effects. The study also looks at other important things, like how many people need intensive care, how long they stay in hospital, and if there are any side effects from the aspirin, especially bleeding. This is a large study (Phase III) happening at multiple hospitals, aiming to get clear answers that could help treat pneumonia in the future.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Dijon

Enrolment target

600

Start

04 Dec 2024

acute pneumonia

What is this study about?

Imagine someone, especially an older person, gets very sick with pneumonia, which is a serious lung infection. Doctors are always looking for better ways to help them recover. This study, called ASPAPY, is testing if a common and inexpensive drug, aspirin, could make a difference.

The main question this study wants to answer is whether aspirin can improve the chances of survival for older people with pneumonia. Specifically, they're looking at what percentage of patients are still alive 90 days after they start treatment. To do this fairly, some patients will receive aspirin, and others will receive a 'dummy' pill (called a placebo). Neither the patients nor their doctors will know who is getting what, which helps make the results as reliable as possible.

Besides survival, the researchers are also interested in other important aspects of recovery. They will track things like how long patients stay in hospital, if they need intensive care, and if they have any heart-related problems. They will also carefully monitor for any side effects of aspirin, such as bleeding, to make sure it's safe. The goal is to find out if aspirin is a safe and effective extra treatment that could help older people with pneumonia.

Key takeaways

This study is testing if aspirin can help older people with severe pneumonia.
It compares aspirin to a 'dummy' drug to see if it improves survival and recovery.
The main focus is on how many people are alive 90 days after starting treatment.
Researchers will also track hospital stays, intensive care needs, and possible side effects like bleeding.
Participation involves receiving one of the treatments and being closely monitored for up to 120 days.

Who may be eligible?

This study is open to both men and women of any age who have recently been diagnosed with severe pneumonia. There aren't specific age limits, so elderly patients are certainly included.

To be considered for this study, you would need to have been admitted to hospital with a confirmed diagnosis of acute (meaning sudden and severe) pneumonia. Your doctors would need to check other aspects of your health to make sure joining the study is safe and appropriate for you.

Generally, those who are too unwell or have certain pre-existing medical conditions that might make aspirin unsafe for them would not be able to join. Your doctor will carefully review your medical history to see if you meet all the necessary criteria.

Quick self-check

I have been admitted to hospital recently with severe pneumonia.
I am open to receiving either aspirin or a dummy drug.
My doctors think it is safe for me to take part.
I am able to attend follow-up appointments or receive calls for up to 4 months.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are invited to take part in this study, you would receive either the aspirin treatment or a dummy pill (placebo) alongside your usual pneumonia care. The aspirin treatment will be given either as a powder mixed into an injection or as a tablet that protects your stomach, depending on what's best for you.

Throughout the study, doctors and nurses will monitor your health closely, just like they normally would for someone with pneumonia. They will pay special attention to how you are recovering, your hospital stay, and any side effects. You might have extra assessments during your hospital stay and at certain times after you leave, such as at 30, 90, and 120 days after starting the treatment. These follow-up checks help the researchers understand the long-term effects of the treatment. The total duration of active monitoring for the study would be up to 120 days (about four months).

Potential risks and benefits

Taking part in this study might mean you receive a treatment (aspirin) that could potentially help your recovery from pneumonia, or it might not have any effect. We don’t yet know if aspirin is truly beneficial for this specific condition, which is why the study is being done. Like all medicines, aspirin can have side effects, the most significant risk being bleeding problems. The study will carefully monitor for these. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is pneumonia?

Pneumonia is a serious infection of the lungs that can make breathing very difficult. It often needs hospital treatment, especially for older people.

What is aspirin normally used for?

Aspirin is a common medicine often used for pain relief, reducing fever, and thinning the blood to help prevent heart attacks or strokes.

Will I know if I'm getting aspirin or the dummy pill?

No, neither you nor your doctors will know whether you are receiving aspirin or the placebo. This helps ensure the study results are fair and unbiased.

Why are they studying aspirin for pneumonia?

Researchers believe aspirin might help reduce inflammation and prevent blood clots, which could potentially benefit patients with severe pneumonia. This study aims to find out if this is true.

What happens after the study ends?

After your participation, you will continue with your regular medical care. The results of the study will be analysed to see if aspirin is a safe and effective treatment that could eventually help other patients.