Acute PneumoniaPhase 3ASPAPYNCT06774846
Aspirin in Acute Pneumonia in the Elderly: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial.
A Phase 3 study testing Acetylsalicylic acid/Aspirin (100 mg) in people with Acute Pneumonia and Elderly Person, run by Centre Hospitalier Universitaire Dijon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Pneumonia, Elderly Person
- What is being tested?
- Acetylsalicylic acid/Aspirin (100 mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jul 2028to Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Acute Pneumonia, Elderly Person
- Being tested
- Acetylsalicylic acid/Aspirin (100 mg), Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 chlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Acetylsalicylic acid/Aspirin (100 mg) |
| Control | Placebo comparator | Not described Receives: Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study startJul 2028 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PneumoniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774846
- Sponsor's protocol ID
- PUTOT PHRCN 2020
- Acronym
- ASPAPY
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin in Acute Pneumonia in the Elderly: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT06774846
- Acronym / sponsor ID
- ASPAPY / PUTOT PHRCN 2020
- Conditions
- Acute Pneumonia, Elderly Person
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2028 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Acetylsalicylic acid/Aspirin (100 mg) |
| Control | Placebo comparator | Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid/Aspirin (100 mg)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. | Drug | Experimental |
| Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloridepatients 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. | Drug | Control |
Primary outcome
All-cause mortality
Time frame: 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid/Aspirin (100 mg) in people with Acute Pneumonia and Elderly Person, run by Centre Hospitalier Universitaire Dijon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain PUTOT (04 50 47 30 89, a.putot@ch-sallanches-chamonix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.