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: a Non-inferiority Randomized Controlled Trial
Led by Nantes University Hospital · Updated on 2026-04-08
326
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two antibiotic treatments for community-acquired pneumonia (CAP) in patients aged 65 years or older who are hospitalized in non-intensive care unit (ICU) wards. The study aims to compare the clinical effectiveness and safety of amoxicillin alone versus amoxicillin combined with clavulanate. This trial addresses an important gap in evidence about the best antibiotic choice for older adults with CAP, as current broad-spectrum antibiotic use is debated due to possible side effects and antibiotic resistance concerns. Participants will be randomly assigned to receive either amoxicillin or amoxicillin/clavulanate for 5 days. Both medications are approved for treating respiratory infections and can be given orally or intravenously. Amoxicillin is given as 500 mg capsules or 1 g IV every 8 hours, while amoxicillin/clavulanate is given as tablets containing 500 mg amoxicillin with 62.5 mg clavulanate or IV vials with 1 g amoxicillin and 200 mg clavulanate every 8 hours. This open-label, non-inferiority trial will compare outcomes at 30 days after treatment begins. During the study, participants will be monitored for clinical responses, cure rates, antibiotic treatment duration, hospital stay length, mortality, and adverse events related to antibiotics. Researchers will also track pneumonia recurrence, ICU transfers, and compliance with treatment. Follow-up assessments include clinical evaluations and laboratory tests up to 30 days after hospital admission. The study will provide important data to guide antibiotic use in older adults with CAP.
CONDITIONS
Brief 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 in immunocompetent status
- Hospitalized for community-acquired pneumonia with at least two clinical signs and radiological confirmation
- Able to understand oral and written French
- Provided written informed consent (or by trusted person if unable)
- Able to call or answer phone calls or have a relative assist with communication
You will not qualify if you...
- Signs of severe community-acquired pneumonia or requiring ICU admission
- Estimated Glomerular Filtration Rate below 30 ml/min
- Known immunosuppression or specific immune conditions
- Exacerbation of chronic obstructive pulmonary disease
- Life-threatening condition expected to cause imminent death
- Suspected atypical bacteria or Legionella infection needing combined antibiotics
- Suspected healthcare-associated pneumonia with resistant pathogens
- Colonization with Pseudomonas aeruginosa or Enterobacteriaceae in respiratory tract
- Suspicion of aspiration pneumonia
- Received antibiotic treatment for more than 24 hours before inclusion
- History of jaundice or liver impairment related to amoxicillin/clavulanate
- Recent bacterial pneumonia within 1 month
- Allergies to beta-lactam antibiotics or excipients
- No health insurance or difficulties with follow-up
- Under judicial protection
- Confirmed SARS-CoV-2 infection
- Participation in another interventional study with overlapping periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either amoxicillin or amoxicillin/clavulanate antibiotic treatment for community-acquired pneumonia for 5 days.
Daily visits during treatment
Duration - Up to 30 days
Participants are monitored for clinical efficacy, safety, and outcomes up to 30 days after treatment starts.
1 visit at Day 30 after inclusion
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
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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