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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Not yet enrolling

Phase 3

Conditions

Acute Pneumonia

Elderly Person

Treatments

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

Drug: Acetylsalicylic acid/Aspirin (100 mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT06774846

PUTOT PHRCN 2020

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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