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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
Sponsor: Nantes University Hospital
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.
Official title: 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: a Non-inferiority Randomized Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
326
Start Date
2024-04-25
Completion Date
2027-05-25
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
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)
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)
Locations (19)
CH Saint-Nazaire
Saint-Nazaire, France, France
CH Saint-Nazaire
Saint-Nazaire, France, France
Chu Angers
Angers, France
CHU Angers
Angers, France
CHU Avicenne AP-HP
Bobigny, France
CHU Avicenne AP-HP
Bobigny, France
CHRU Brest
Brest, France
CHRU Brest
Brest, France
CHD Vendée
La Roche-sur-Yon, France
CHD Vendée
La Roche-sur-Yon, France
CHU Grenoble-Alpes
La Tronche, France
CHU Grenoble-Alpes
La Tronche, France
Assistance Publique Hopitaux De Marseille
Marseille, France
CHU de Nantes
Nantes, France
CH Perigueux
Périgueux, France
CHRU - TOULOUSE Hôpital Purpan
Toulouse, France
CHRU - TOULOUSE Hôpital Purpan
Toulouse, France
CHRU TOULOUSE - Hôpital Rangueuil
Toulouse, France
Centre Hospitalier Bretagne Atlantique
Vannes, France