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Comparing Amoxicillin and Amoxicillin/Clavulanate for Pneumonia in Older Adults

Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward: a Non-inferiority Randomized Controlled Trial

Phase 3 Interventional Nantes University Hospital · NCT06229288

This study is testing whether amoxicillin works just as well as a combination of amoxicillin and clavulanate for treating pneumonia in older adults who are hospitalized.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment326 (estimated)
Ages65 Years and up
SexAll
SponsorNantes University Hospital Academic / other
Locations19 sites (Saint-Nazaire, France and 18 other locations)
Trial IDNCT06229288 on ClinicalTrials.gov

What this trial studies

This trial aims to compare the clinical efficacy and safety of two antibiotic treatments, amoxicillin and amoxicillin/clavulanate, for community-acquired pneumonia (CAP) in patients aged 65 years or older who are hospitalized in non-intensive care units. It is a multi-center, randomized, open-label, non-inferiority trial that will evaluate patient outcomes at Day 30 post-treatment. The study seeks to provide evidence that could inform treatment guidelines for CAP, particularly in older adults who may have different responses to antibiotics.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 years or older, hospitalized for community-acquired pneumonia with specific clinical signs and radiological evidence.

Not a fit: Patients with severe community-acquired pneumonia or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer antibiotic prescribing practices for older patients with pneumonia.

How similar studies have performed: Previous studies have indicated the need for more head-to-head comparisons of antibiotics for pneumonia, suggesting this approach is both relevant and necessary.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Saint-Nazaire, France and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Community-acquired PneumoniaCommunity-acquired pneumoniaAmoxicillinAmoxicillin/clavulanate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.