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

NCT06774846 | Not Yet Recruiting Phase 3

• 1 other identifier: PUTOT PHRCN 2020
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Pneumonia; Elderly Person

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  90 days after randomization

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: Acetylsalicylic acid/Aspirin (100 mg)

Control

PLACEBO COMPARATOR

Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride

Interventions

Acetylsalicylic acid/Aspirin (100 mg) DRUG

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.

Experimental

Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride DRUG

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.

Control

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mechanically ventilated pneumonia
• Documented SARS CoV2 pneumonia
• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Alain PUTOT

CONTACT

04 50 47 30 89; a.putot@ch-sallanches-chamonix.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09