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

Summary

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.

Conditions

• Community-acquired Pneumonia

Interventions

DRUG

Amoxicillin

Participants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections. Amoxicillin PO: The dose is two capsule of 500 mg every 8 hours (that is 3 times daily). Amoxicillin IV: The dose is 1 g every 8 hours (that is 3 times daily)

DRUG

Amoxicillin/clavulanate

Participants will be randomized to IV/oral amoxicillin or IV/oral amoxicillin/clavulanate for 5 days. Both agents are approved for treatment of respiratory infections. Amoxicillin/clavulanate PO: The dose is two tablets of 500 mg/62.5 mg every 8 hours (that is 3 times daily, approved standard dose) Amoxicillin/clavulanate IV: The dose is 1 g/200 mg every 8 hours (that is 3 times daily, approved standard dose)

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Frederic BALEN, Doctor · Toulouse UH

• Guillaume MARTIN-BLONDEL, Doctor · Toulouse UH

• Perrine DUMANOIR, Doctor · Grenoble Hospital

• VIGLINO Damien, Doctor · Grenoble Hospital

• Alexandrine VIDAL, Doctor · Perigueux Hospital

• Delphine PLARD, Doctor · Angers UH

• Rafaël MAHIEU, Doctor · Angers UH

• Anne-Laure FERAL-PIERSSENS, Doctor · Avicenne AP-HP

• Frederic MECHAI, Doctor · Avicenne AP-HP

• Aurelie DAUMAS, Professor · Marseille Timone Hospital

• Dominique MERRIEN, Doctor · CHD La Roche sur Yon

• Sylvain LE GENTIL, Doctor · CHD La Roche sur Yon

• Pierre BARSI, Doctor · Vannes Hospital Bretagne Atlantic

• Rozenn LE BERRE, Doctor · Brest Hospital

• Sylvain JAFFUEL, Doctor · Brest Hospital

• Xavier DUBUCS, Doctor · Toulouse UH

• Matthieu THIBAULT, Doctor · Saint-Nazaire Hospital

• BOISSEAU Dorothée, Doctor · Saint-Nazaire Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-25

Primary Completion

2027-05-25

Completion

2027-05-25

Countries

• France

Study Locations