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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age75+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent obtained from patient or relative/trusted person if patient unable to consent

Age ≥75 years

cough,

purulent expectoration,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Time frame
90 days after randomization

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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