Actively Recruiting
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
Eligibility Criteria
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
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
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
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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