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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether low-dose aspirin can help prevent serious heart problems in older adults who have been hospitalized for acute pneumonia. Pneumonia is a common and serious infection that can lead to complications, especially in people over 75 years old. The study aims to understand if taking 100 mg of aspirin each day for 90 days after recovering from pneumonia can improve overall survival and reduce the risk of heart-related issues.

To participate in this trial, individuals need to be at least 75 years old, have a confirmed diagnosis of pneumonia, and have been hospitalized for at least 48 hours. They should have specific symptoms like a cough or fever and must not have certain health conditions that could complicate treatment, such as severe asthma or active bleeding issues. Participants will be randomly assigned to receive either aspirin or a placebo (a dummy treatment) and will be monitored for their health over the study period. This trial is important because it could lead to better care for older patients who are at higher risk after pneumonia, offering them a potential way to improve their recovery and long-term health.

Gender

ALL

Eligibility criteria

• 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)
• • 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)
• • Severe renal insufficiency
• • Hepatic cirrhosis or severe liver failure (TP\<50%),
• • Severe uncontrolled heart failure
• • Severe uncontrolled hypertension (PAS \> 180mmHg)
• • Patient with mastocytosis
• • Person not affiliated to a national social security scheme
• • Patient under court protection