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Aspirin in acute pneumonia in the elderly: a multicenter, double-blind, randomized, placebo-controlled trial
EU CTIS ID: 2024-510811-32-00
What this study is testing
To evaluate the efficacy of aspirin on all-cause mortality after AP at 90 days (D90) after randomization.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent obtained from the patient or a relative/trusted person if the patient is unable to consent
- Age ≥75 years
- Clinical diagnosis of AP, presumed to be of bacterial or viral origin, with at least two of the following signs or symptoms: - cough, - purulent expectoration, - thoracic pain, - dyspnea/tachypnea, - temperature > 37.8°C or < 36°C, - unilateral crackles
- Patient hospitalized for at least 48 hours
- Onset of clinical signs < 7 days
- New radiological infiltrate documented by X-ray, ultrasound or CT scan
You likely can't join if
- Mechanically ventilated pneumonia
- Antiplatelet therapy
- Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without a proton pump inhibitor (PPI)
- Dyspepsia or gastroesophageal reflux disease (GERD) without PPIs
- Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide
- Contraindications to aspirin (preventive doses) or its placebo: •Hypersensitivity to acetylsalicylic acid or to any of the excipients of the investigational drug or placebo; • History of asthma induced by the administration of salicylates or non-steroidal anti-inflammatory drugs; • Active peptic ulcer disease or history of recurrent peptic ulcer disease; •History of cerebrovascular hemorrhage; •Previous gastrointestinal hemorrhage; •History of hemorrhage with Hemoglobin > 3g /dl requiring transfusion, vasoactive treatment or surgery; •Known hereditary or acquired coagulation disorder; •Thrombocytopenia (platelets < 50 giga/L); •Acute kidney injury (clairance < 15 ml/min selon MDRD - Modification of Diet in Renal Disease); •Liver cirrhosis or acute liver failure (PTT<50%); •Severe uncontrolled heart failure; •Persistent severe hypertension (systolic blood pressure > 180mmHg); •Patient with mastocytosis
See the full eligibility criteria
Who can join
- Informed consent obtained from the patient or a relative/trusted person if the patient is unable to consent
- Age ≥75 years
- Clinical diagnosis of AP, presumed to be of bacterial or viral origin, with at least two of the following signs or symptoms: - cough, - purulent expectoration, - thoracic pain, - dyspnea/tachypnea, - temperature > 37.8°C or < 36°C, - unilateral crackles
- Patient hospitalized for at least 48 hours
- Onset of clinical signs < 7 days
- New radiological infiltrate documented by X-ray, ultrasound or CT scan
What rules you out
- Mechanically ventilated pneumonia
- Antiplatelet therapy
- Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without a proton pump inhibitor (PPI)
- Dyspepsia or gastroesophageal reflux disease (GERD) without PPIs
- Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide
- Contraindications to aspirin (preventive doses) or its placebo: •Hypersensitivity to acetylsalicylic acid or to any of the excipients of the investigational drug or placebo; • History of asthma induced by the administration of salicylates or non-steroidal anti-inflammatory drugs; • Active peptic ulcer disease or history of recurrent peptic ulcer disease; •History of cerebrovascular hemorrhage; •Previous gastrointestinal hemorrhage; •History of hemorrhage with Hemoglobin > 3g /dl requiring transfusion, vasoactive treatment or surgery; •Known hereditary or acquired coagulation disorder; •Thrombocytopenia (platelets < 50 giga/L); •Acute kidney injury (clairance < 15 ml/min selon MDRD - Modification of Diet in Renal Disease); •Liver cirrhosis or acute liver failure (PTT<50%); •Severe uncontrolled heart failure; •Persistent severe hypertension (systolic blood pressure > 180mmHg); •Patient with mastocytosis
- Person not affiliated to a national health insurance
- Patient under court protection
- Documented SARS CoV2 pneumonia
- Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion
- Pre-acute swallowing disorders impairing oral medication intake
- Physician-assessed life expectancy < 90 days
- Anticoagulant treatment (curative doses)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.