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

Launched by NANTES UNIVERSITY HOSPITAL · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial, called CAPTAIN, is examining the effectiveness of two different antibiotics for treating community-acquired pneumonia (CAP) in patients aged 65 and older who are hospitalized but not in intensive care. The trial is comparing amoxicillin alone to a combination of amoxicillin and clavulanate. The goal is to find the best treatment option while also helping to reduce unnecessary use of broad-spectrum antibiotics, which can lead to antibiotic resistance and other side effects.

To participate, patients must be at least 65 years old and have been admitted to the hospital with symptoms of pneumonia, such as a cough or fever, along with a confirmed diagnosis from a chest X-ray. They should also be able to communicate in French and provide consent to join the study. Those with more severe pneumonia or certain health conditions, like requiring intensive care or having a weakened immune system, will not be eligible. Participants can expect close monitoring throughout the study, and their health outcomes will be carefully assessed to determine which antibiotic is more effective.

Gender

ALL

Eligibility 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