Comparing Amoxicillin Alone to AmoxicillinClavulanate for Treating Pneumonia in Patients 65 Years and Older Hospitalized Outside ICU

What this Trial Is About

Researchers are evaluating two antibiotic treatments for community-acquired pneumonia CAP in patients aged 65 years or older who are hospitalized in non-intensive care unit ICU wards. The study aims to compare the clinical effectiveness and safety of amoxicillin alone versus amoxicillin combined with clavulanate. This trial addresses an important gap in evidence about the best antibiotic choice for older adults with CAP, as current broad-spectrum antibiotic use is debated due to possible side effects and antibiotic resistance concerns. Participants will be randomly assigned to receive either amoxicillin or amoxicillinclavulanate for 5 days. Both medications are approved for treating respiratory infections and can be given orally or intravenously. Amoxicillin is given as 500 mg capsules or 1 g IV every 8 hours, while amoxicillinclavulanate is given as tablets containing 500 mg amoxicillin with 62.5 mg clavulanate or IV vials with 1 g amoxicillin and 200 mg clavulanate every 8 hours. This open-label, non-inferiority trial will compare outcomes at 30 days after treatment begins. During the study, participants will be monitored for clinical responses, cure rates, antibiotic treatment duration, hospital stay length, mortality, and adverse events related to antibiotics. Researchers will also track pneumonia recurrence, ICU transfers, and compliance with treatment. Follow-up assessments include clinical evaluations and laboratory tests up to 30 days after hospital admission. The study will provide important data to guide antibiotic use in older adults with CAP.

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