Aspirine dans la pneumonie aiguë chez les personnes âgées : un essai multicentrique, en double aveugle, randomisé et contrôlé par placebo. (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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alain PUTOT
- Numéro de téléphone: 04 50 47 30 89
- E-mail: a.putot@ch-sallanches-chamonix.fr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Expérimental
|
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. |
|
Comparateur placebo: Contrôler
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Mortalité toutes causes confondues
Délai: 90 jours après la randomisation
|
90 jours après la randomisation
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PUTOT PHRCN 2020
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .