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Could a common antibiotic replace stronger drugs for pneumonia in seniors?

NCT ID NCT06229288

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares amoxicillin alone to amoxicillin/clavulanate for treating community-acquired pneumonia in adults aged 65 and older who are hospitalized but not in intensive care. The goal is to see if the narrower antibiotic works just as well, which could reduce side effects and slow antibiotic resistance. About 326 participants will be randomly assigned to one of the two treatments for 5 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amoxicillin and amoxicillin/clavulanate
What this could lead to
If successful, this could show that a narrower antibiotic (amoxicillin alone) is just as effective as a broader one, reducing side effects and antibiotic resistance.
What could go wrong
This is a single trial with 326 participants, so results may not apply to all older adults. There is a risk that amoxicillin alone may not work as well in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients, 2. Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature \> 38°C) or hypothermia (\<36°C)), and had radiological evidence of a new infiltrate confirming pneumonia 3. Patient understanding oral and written French 4. Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person). 5. Patients should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by a medical staff belonging to the investigational site Exclusion Criteria: 1. Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission) 2. Patient requiring ICU admission, 3. Estimated Glomerular Filtration Rate \< 30 ml/min, 4. Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4\<200/mm3), 5. Exacerbation of chronic obstructive pulmonary disease, 6. Life-threatening state expected to lead to possible imminent death, 7. Suspected atypical bacteria requiring combined antibiotics therapy, 8. Legionella suspected, 9. Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility) 10. Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract, 11. Suspicion of aspiration pneumonia, 12. Administration of any antibiotic treatment for more than 24 hours before inclusion, 13. History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid, 14. History of bacterial pneumonia less than 1 month prior to study inclusion 15. History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics, 16. Subject without health insurance, 17. Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation), 18. Patient under judicial protection, 19. Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chest computed tomography (CT) scan), 20. Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-acquired pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique Hopitaux De Marseille

    RECRUITING

    Marseille, France

  • CH Perigueux

    RECRUITING

    Périgueux, France

  • CH Saint-Nazaire

    RECRUITING

    Saint-Nazaire, France, 44600, France

  • CH Saint-Nazaire

    RECRUITING

    Saint-Nazaire, France, 44600, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHRU - TOULOUSE Hôpital Purpan

    RECRUITING

    Toulouse, France

  • CHRU - TOULOUSE Hôpital Purpan

    RECRUITING

    Toulouse, France

  • CHRU Brest

    RECRUITING

    Brest, France

  • CHRU Brest

    RECRUITING

    Brest, France

  • CHRU TOULOUSE - Hôpital Rangueuil

    RECRUITING

    Toulouse, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Avicenne AP-HP

    RECRUITING

    Bobigny, France

  • CHU Avicenne AP-HP

    RECRUITING

    Bobigny, France

  • CHU Grenoble-Alpes

    RECRUITING

    La Tronche, France

  • CHU Grenoble-Alpes

    RECRUITING

    La Tronche, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • Centre Hospitalier Bretagne Atlantique

    RECRUITING

    Vannes, France

  • Chu Angers

    RECRUITING

    Angers, France

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