Actively Recruiting

Phase 3
Age: 65Years +
All Genders
NCT06229288

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

Led by Nantes University Hospital · Updated on 2026-04-08

326

Participants Needed

19

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 65 years or older with or without chronic diseases and immunocompetent
  • Hospitalized for community-acquired pneumonia confirmed by at least two clinical signs (cough, sputum, breathing difficulty, rapid breathing, chest pain, abnormal lung sounds, fever or low temperature) and a new infiltrate on chest X-ray
  • Able to understand spoken and written French
  • Provided written informed consent or consent given by a trusted person if unable to write
  • Able to answer or receive phone calls or have a relative assist in communication with medical staff
Not Eligible

You will not qualify if you...

  • Signs of severe community-acquired pneumonia (abscess, large pleural effusion, serious chronic respiratory failure, ICU admission)
  • Need for ICU admission
  • Estimated kidney function below 30 ml/min
  • Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, HIV with low CD4 count)
  • Exacerbation of chronic obstructive pulmonary disease
  • Life-threatening condition with expected imminent death
  • Suspected atypical bacterial infection needing combined antibiotics
  • Suspected Legionella infection
  • Suspected healthcare-associated pneumonia with resistant bacteria
  • Known colonization with Pseudomonas aeruginosa or Enterobacteriaceae in the lungs
  • Suspected aspiration pneumonia
  • More than 24 hours of antibiotic treatment before joining the study
  • History of liver problems linked to amoxicillin/clavulanate
  • Bacterial pneumonia within 1 month prior to study
  • Known allergy to beta-lactam antibiotics or any ingredients in study drugs
  • No health insurance
  • No home address or difficulty with follow-up (travel, job change, distance, low motivation)
  • Under judicial protection
  • Confirmed COVID-19 infection
  • Participation in another interventional study with overlapping exclusion period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

CH Saint-Nazaire

Saint-Nazaire, France, France, 44600

Actively Recruiting

2

CH Saint-Nazaire

Saint-Nazaire, France, France, 44600

Actively Recruiting

3

Chu Angers

Angers, France

Actively Recruiting

4

CHU Angers

Angers, France

Actively Recruiting

5

CHU Avicenne AP-HP

Bobigny, France

Actively Recruiting

6

CHU Avicenne AP-HP

Bobigny, France

Actively Recruiting

7

CHRU Brest

Brest, France

Actively Recruiting

8

CHRU Brest

Brest, France

Actively Recruiting

9

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

10

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

11

CHU Grenoble-Alpes

La Tronche, France

Actively Recruiting

12

CHU Grenoble-Alpes

La Tronche, France

Actively Recruiting

13

Assistance Publique Hopitaux De Marseille

Marseille, France

Actively Recruiting

14

CHU de Nantes

Nantes, France

Actively Recruiting

15

CH Perigueux

Périgueux, France

Actively Recruiting

16

CHRU - TOULOUSE Hôpital Purpan

Toulouse, France

Actively Recruiting

17

CHRU - TOULOUSE Hôpital Purpan

Toulouse, France

Actively Recruiting

18

CHRU TOULOUSE - Hôpital Rangueuil

Toulouse, France

Actively Recruiting

19

Centre Hospitalier Bretagne Atlantique

Vannes, France

Actively Recruiting

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Research Team

E

Emmanuel MONTASSIER, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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