Aspirin in Acute Pneumonia in the Elderly: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial. (ASPAPY)

Acute pneumonia is a very common disease, and one of the leading causes of hospitalization and death in France. Almost a century after the discovery of penicillin, no major breakthrough has significantly reduced pneumonia-related mortality. While the choice of an appropriate antibiotic is decisive in the acute phase of the disease, the longer-term prognosis depends essentially on the worsening of other underlying pathologies, particularly in the elderly. In cured patients, excess mortality persists several months after the episode of pneumonia, due in particular to the onset of cardiovascular complications. Recent scientific literature shows an association between the prescription of cardio-protective drugs and survival after pneumonia. Older patients are usually excluded from interventional studies, so there are no specific recommendations for these patients at high risk of both acute pneumonia and cardiovascular events.

The aim of this study is to assess the efficacy of low-dose aspirin therapy after pneumonia in preventing cardiovascular events in the elderly.

The main objective is therefore to evaluate the impact of aspirin at a dose of 100mg per day on all-cause mortality at 90 days in patients over 75 years of age hospitalized for pneumonia.

Study Overview

• Status: Not yet recruiting
• Conditions: Elderly Person; Acute Pneumonia
• Intervention / Treatment: Drug: Acetylsalicylic acid/Aspirin (100 mg); Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alain PUTOT; Phone Number: 04 50 47 30 89; Email: a.putot@ch-sallanches-chamonix.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent obtained from patient or relative/trusted person if patient 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

Exclusion Criteria:

• Mechanically ventilated pneumonia
• Documented SARS CoV2 pneumonia
• Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion
• Pre-acute episode swallowing disorders impairing oral medication intake
• Physician-assessed life expectancy < 90 days
• Anticoagulant treatment (curative doses)
• Antiplatelet therapy
• Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without proton pump inhibitor (PPI)
• Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide
• Dyspepsia or gastroesophageal reflux disease (GERD) without PPI use
• Contraindications to aspirin (preventive doses) or its placebo at the time of inclusion:
• 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 haemorrhage
• 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
• Persistente severe hypertension (PAS > 180mmHg)
• Patient with mastocytosis
• Person not affiliated to a national social security scheme
• Patient under court protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Drug: Acetylsalicylic acid/Aspirin (100 mg); Patients will receive 100 mg acetylsalicylic acid (or Aspirin) orally (tablet) once a day (or intravenously if oral administration is not possible in the acute phase of pneumonia), introduced within 84 hours of pneumonia diagnosis, for 90 days.
Placebo Comparator: Control	Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride; patients in the placebo group will receive 100 mg placebo acetylsalicylic acid orally (tablet) once a day (or intravenously if oral administration is not possible in the acute phase of pneumonia), introduced within 84 hours of pneumonia diagnosis, for 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	90 days after randomization

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: PUTOT PHRCN 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No