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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorNantes University Hospital

About this trial

Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions.

In the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Thus, the choice of the empirical antibiotic depends on the most likely pathogen, individual risk factors, comorbidities, and allergies.

Patients aged 65 years or older are often treated with amoxicillin/clavulanate or with another broad-spectrum antibiotic (third-generation cephalosporins, antipneumococcal fluoroquinolone). However, broad-spectrum antibiotic prescription in CAP is debated and concerns exist about side-effects and selective pressure for resistance. Due to lack of head-to-head antibiotic comparisons, a recent Cochrane review concluded that current evidence from Randomized Clinical Trials (RCTs) is insufficient to make evidence-based recommendations for the choice for antibiotic to be used, highlighting an important evidence gap.

Eligibility criteria

Qualifiers

Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients,

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

Patient understanding oral and written French

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).

Disqualifiers

Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission)

Patient requiring ICU admission,

Estimated Glomerular Filtration Rate < 30 ml/min,

Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3),

Trial design

Treatments tested in this trial

  • Amoxicillin
  • Amoxicillin/clavulanate

Treatment groups

326 Participants
are divided into 2 treatment groups

Sponsors and collaborators