Aspirin in acute pneumonia in the elderly: a multicenter, double-blind, randomized, placebo-controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-12-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-510811-32-00

ClinicalTrials.gov

NCT06774846

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of aspirin on all-cause mortality after AP at 90 days (D90) after randomization.

Secondary objectives 11

1. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on All-cause mortality at D30 and D120
2. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*)
3. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on incidence of major CV events (*myocardial infarction, stroke, acute heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization.
4. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on length of stay in intensive care or resuscitation unit within 90 days of randomization
5. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on unscheduled rehospitalization within 30 and 90 days of randomization (excluding follow-up care and rehabilitation units and long-term care units)
6. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on length of first hospital stay (excluding follow-up care and rehabilitation units and long-term care units)
7. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on dependence at D90
8. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on overall survival at D120
9. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on major CV event-free survival at D120
10. EFFICACY: to evaluate the efficacy of aspirin (100 mg/day for 90 days) on all primary and secondary CJs in various subgroups
11. TOLERANCE: to assess the tolerability of aspirin

Conditions and MedDRA coding

acute pneumonia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Informed consent obtained from the patient or a relative/trusted person if the patient is unable to consent
2. Age ≥75 years
3. 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
4. Patient hospitalized for at least 48 hours
5. Onset of clinical signs < 7 days
6. New radiological infiltrate documented by X-ray, ultrasound or CT scan

Exclusion criteria 13

1. Mechanically ventilated pneumonia
2. Contraindications to aspirin (preventive doses) or its placebo: •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 hemorrhage; •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; •Persistent severe hypertension (systolic blood pressure > 180mmHg); •Patient with mastocytosis
3. Person not affiliated to a national health insurance
4. Patient under court protection
5. Documented SARS CoV2 pneumonia
6. Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion
7. Pre-acute swallowing disorders impairing oral medication intake
8. Physician-assessed life expectancy < 90 days
9. Anticoagulant treatment (curative doses)
10. Antiplatelet therapy
11. Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without a proton pump inhibitor (PPI)
12. Dyspepsia or gastroesophageal reflux disease (GERD) without PPIs
13. Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. All-cause mortality at D90 after randomization

Secondary endpoints 11

1. EFFICACY: All-cause mortality at D30 and D120
2. EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*)
3. EFFICACY: Occurrence of major CV events (composite endpoint including at least one of the following: *myocardial infarction, stroke, heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization
4. EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization
5. EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization
6. EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units)
7. EFFICACY: Proportion of newly institutionalized patients (i.e. entering a nursing home) at D90 and proportion of patients with a decrease ≥ 1 point on the activity of daily living (ADL) scale between their pre-randomization status and D90
8. EFFICACY: Time (in days) to death from any cause, end of study (D120) or date of last follow-up, whichever comes first
9. EFFICACY: Time (in days) to major CV event, death, end of study (D120) or date of last follow-up, whichever comes first
10. TOLERANCE: Frequency of major bleeding events (BARC classification >2) within 30 days, 90 days and 120 days of randomization
11. TOLERANCE: Frequency of bleeding events (any severity) within 30 days, 90 days and 120 days of randomization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications