Search / Trial NCT06229288

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

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Community Acquired Pneumonia Amoxicillin Amoxicillin/Clavulanate

Description

Thus, the goal of the proposed trial is to compare clinical efficacy and safety of two CAP antimicrobial treatments, amoxicillin and amoxicillin/clavulanate, in patients aged 65 years or older and hospitalized in a non-intensive care unit (ICU) ward. The CAPTAIN study will be a multi-center, randomized, open, non-inferiority trial comparing clinical efficacy at Day 30 among patients ≥65 years of age, and hospitalized in a non-ICU ward, treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy for CAP. This will be a pivotal clinical tri...

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. Intercurrent infection requiring antibiotic treatment,
  • 13. Administration of beta-lactam therapy for more than 24 hours before inclusion,
  • 14. History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid,
  • 15. History of bacterial pneumonia less than 1 month prior to study inclusion
  • 16. History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics,
  • 17. Subject without health insurance,
  • 18. Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation),
  • 19. Patient under judicial protection,
  • 20. Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chest computed tomography (CT) scan),
  • 21. 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0