Comparing Amoxicillin and Amoxicillin/Clavulanate for Pneumonia in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CH Saint-Nazaire
  Saint-Nazaire, France, France Recruiting
• CH Saint-Nazaire
  Saint-Nazaire, France, France Recruiting
• Chu Angers
  Angers, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Avicenne AP-HP
  Bobigny, France Recruiting
• CHU Avicenne AP-HP
  Bobigny, France Recruiting

Study contacts

• Principal investigator: Frederic BALEN, Doctor — Toulouse UH
• Study coordinator: Emmanuel MONTASSIER, Professor
• Email: emmanuel.montassier@chu-nantes.fr
• Phone: 02 53 48 20 38

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.