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RECRUITING
NCT06229288
PHASE3

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

View on ClinicalTrials.gov

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

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)

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