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A Study of Acetylsalicylic Acid (Aspirin) for Treatment of Acute Pneumonia in Elderly Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on acute pneumonia in elderly patients. The research examines whether acetylsalicylic acid (commonly known as aspirin) can help reduce deaths from any cause in elderly patients with pneumonia. The study will compare aspirin treatment to placebo in patients who are hospitalized with pneumonia symptoms.

The treatment involves giving patients either aspirin or placebo. The aspirin will be given in different forms: as a gastro-resistant tablet, as an intravenous solution, or with sodium chloride solution. The medication or placebo will be given over a period of 90 days while monitoring the patient's condition.

The study will track how many patients survive and what complications they experience, particularly focusing on heart and blood vessel-related problems. Researchers will also monitor for any bleeding that might occur as a side effect of the treatment. The study will follow patients for up to 120 days to understand both the benefits and risks of using aspirin in elderly pneumonia patients.

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

    Initial treatment phase

    After joining the study, you will receive either aspirin or a placebo (inactive substance) through an intravenous line for the first 48 hours of treatment

    The medication will be administered as acetylsalicylic acid 500 mg in solution form, mixed with sodium chloride 0.9% for intravenous use

    Neither you nor your healthcare providers will know which treatment you are receiving, as this is a double-blind study

  2. Step 2

    Continuation phase

    Following the initial 48 hours, you will switch to taking oral tablets

    The medication will be either Aspirin Protect 100 mg gastro-resistant tablets or matching placebo tablets

    You will need to take these tablets daily

  3. Step 3

    Follow-up period

    Your health status will be monitored for 120 days after starting the treatment

    Key check-up points will occur at 30 days, 90 days, and 120 days

    During this period, your healthcare team will track any changes in your condition, including heart-related events and any potential bleeding

  4. Step 4

    Final assessment

    At the end of the 120-day period, there will be a final evaluation of your health status

    The assessment will include reviewing your overall health condition and any changes in your daily activities

    If you have moved to a nursing home during the study period, this information will be recorded

Who can join the trial?

11 criteria

  • Patient or their relative/trusted person must provide informed consent to participate in the study
  • Must be 75 years of age or older
  • Must have a clinical diagnosis of acute pneumonia (lung infection) with at least two of these symptoms:
    • Cough
    • Coughing up mucus
    • Chest pain
    • Difficulty breathing or rapid breathing
    • Body temperature above 37.8°C (100°F) or below 36°C (96.8°F)
    • Crackling sounds heard in one lung during examination
    • Must be hospitalized for at least 48 hours
    • Symptoms must have started less than 7 days before enrollment
    • Must have evidence of infection on chest imaging (X-ray, ultrasound, or CT scan) showing new areas of infection in the lungs

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known allergic reaction or sensitivity to aspirin
  • Active or recent bleeding disorders (conditions that affect blood clotting)
  • Current use of blood-thinning medications (anticoagulants)
  • History of stomach ulcers or gastrointestinal bleeding
  • Severe liver disease
  • Severe kidney disease
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Recent major surgery (within the last month)
  • Severe thrombocytopenia (low blood platelet count)
  • Uncontrolled high blood pressure
  • History of hemorrhagic stroke (bleeding in the brain)
  • Severe heart failure
  • Unable to provide informed consent
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Investigated drugs

Aspirin is a common medication used to reduce pain, fever, and inflammation. In this trial, it is being studied for its potential effects in elderly patients with acute pneumonia. Aspirin also has blood-thinning properties and can help prevent blood clots. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is already known about the treatment

Aspirin - An oral medication available in tablet form that belongs to the nonsteroidal anti-inflammatory drug (NSAID) class and works by inhibiting the production of prostaglandins, substances responsible for pain, fever, and inflammation. This widely studied and well-documented medication is primarily used for pain relief, fever reduction, and prevention of cardiovascular events, but is now being investigated for potential benefits in elderly patients with acute pneumonia. Aspirin's mechanism of action involves blocking cyclooxygenase enzymes (COX-1 and COX-2) in the body, which may help reduce inflammation in the lungs and potentially improve outcomes in pneumonia patients.

Investigated diseases

  • Acute Pneumonia

    An infection causing inflammation of the air sacs in one or both lungs. The air sacs may fill with fluid or pus, causing symptoms such as cough, fever, chills, and difficulty breathing. The condition develops quickly, typically over a few days. The infection can affect people of any age, with symptoms ranging from mild to severe. The air sacs inflammation leads to decreased oxygen exchange in the lungs.

  • Myocardial Infarction

    Commonly known as a heart attack, occurs when blood flow to a part of the heart muscle is blocked. This blockage is usually caused by a buildup of fatty deposits in the arteries. When blood flow is restricted, the heart muscle begins to die due to lack of oxygen. The condition typically causes chest pain, shortness of breath, and discomfort in the upper body.

  • Stroke

    A condition where blood flow to an area of the brain is cut off. When brain cells don't get oxygen, they begin to die. The effects of stroke depend on which area of the brain is affected. It can cause sudden numbness or weakness, confusion, trouble speaking, or problems with vision and balance.

  • Heart Failure

    A chronic condition where the heart can't pump blood as well as it should. The heart continues working, but not as efficiently as needed. This leads to fatigue, shortness of breath, and swelling in the legs. The condition usually develops gradually over time.

  • Atrial Fibrillation

    An irregular and often rapid heart rhythm that occurs when the upper chambers of the heart experience chaotic electrical signals. This causes poor blood flow through the heart. Common symptoms include heart palpitations, shortness of breath, and weakness.

  • Pulmonary Embolism

    A blockage in one of the pulmonary arteries in the lungs. Most commonly, the blockage is caused by blood clots that travel from the legs to the lungs. This condition can cause difficulty breathing, chest pain, and cough.

Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-510811-32-00Protocol codeASPAPYEstimated enrolment600 patientsSponsorCentre Hospitalier Universitaire De Dijon

sourced from the EU Clinical Trials Register and site verification

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