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Study Comparing Amoxicillin and Amoxicillin/Clavulanic Acid for Treating Community-Acquired Pneumonia in Patients Aged 65 and Older

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of community-acquired pneumonia in patients who are 65 years or older and are hospitalized in a regular hospital ward, not in intensive care. The study compares two treatments: one using amoxicillin alone and the other using a combination of amoxicillin and clavulanic acid. These medications are commonly used antibiotics, with amoxicillin being a narrow-spectrum antibiotic, meaning it targets specific types of bacteria, and the combination with clavulanic acid being a broad-spectrum antibiotic, which targets a wider range of bacteria.

The purpose of the study is to determine if the treatment with amoxicillin alone is as effective as the combination treatment in terms of clinical success. Clinical success is defined as the patient surviving after completing the antibiotic treatment, with the resolution of symptoms such as cough, difficulty breathing, and chest pain, and no new symptoms or complications related to the pneumonia. The study will follow patients for 30 days after they are admitted to the hospital to assess the effectiveness of the treatments.

Participants in the study will receive either the amoxicillin alone or the combination of amoxicillin and clavulanic acid for a maximum of five days. The study will monitor various outcomes, including the improvement of symptoms, the need for additional antibiotics, and overall survival. The study aims to provide valuable information on the best treatment approach for older adults with community-acquired pneumonia who are hospitalized in non-intensive care settings.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. If you are unable to write, a trusted person can provide consent on your behalf.

    You must be 65 years or older, hospitalized for community-acquired pneumonia, and able to understand oral and written French.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking for symptoms like cough, sputum production, difficulty breathing, or chest pain, and reviewing your medical history.

    A chest X-ray or similar imaging will be performed to confirm pneumonia.

  3. Step 3

    Randomization and treatment

    You will be randomly assigned to receive either amoxicillin or amoxicillin/clavulanate.

    If assigned to amoxicillin, you will receive 1 g intravenously or 500 mg orally, depending on your condition.

    If assigned to amoxicillin/clavulanate, you will receive 1 g/200 mg intravenously or 500 mg/62.5 mg orally.

    The treatment will continue as prescribed by the medical team, typically for the duration of your hospital stay.

  4. Step 4

    Monitoring and follow-up

    Your health will be monitored throughout the treatment. This includes regular checks of your symptoms and any side effects.

    You will be contacted by phone or in person to assess your progress and any changes in your condition.

  5. Step 5

    Completion and evaluation

    At the end of the treatment, your symptoms will be evaluated to determine the success of the therapy.

    A follow-up will occur 30 days after hospital admission to assess your recovery and any need for further treatment.

Who can join the trial?

14 criteria

  • Patient must be 65 years or older.
  • Patient can have other long-term health conditions, but must have a normal immune system.
  • Patient must be admitted to the hospital for community-acquired pneumonia (CAP), which is a lung infection.
  • Patient must show at least two signs of pneumonia, such as:
    • Cough
    • Producing mucus (sputum)
    • Difficulty breathing (dyspnea)
    • Fast breathing (tachypnea)
    • Chest pain when breathing (pleuritic pain)
    • Unusual lung sounds when a doctor listens with a stethoscope
    • Fever (temperature over 38°C) or low body temperature (below 36°C)
    • Patient must have a chest X-ray or scan showing a new lung infection.
    • Patient must give written consent to participate in the study. If unable to write, a trusted person can give consent for them.
    • Patient must understand both spoken and written French.
    • Patient must be able to make or receive phone calls, or have a relative who can help with phone communication, especially with the medical team.

Who cannot join the trial?

5 criteria

  • Patients who are younger than 65 years old.
  • Patients who are not hospitalized in a non-ICU ward. An ICU is an Intensive Care Unit, which is a special department in a hospital for very sick patients.
  • Patients who do not have community-acquired pneumonia. This is a type of lung infection that you get outside of a hospital.
  • Patients who are not being treated with either narrow-spectrum or broad-spectrum antimicrobial therapy. **Narrow-spectrum** therapy targets specific types of bacteria, while **broad-spectrum** therapy targets a wider range of bacteria.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

  • Amoxicillin

    is an antibiotic used to treat infections caused by bacteria. In this trial, it is being used to treat community-acquired pneumonia in patients who are 65 years or older and are hospitalized in a regular hospital ward, not in intensive care. The goal is to see if this medication is effective enough on its own to treat the infection.

  • Amoxicillin/Clavulanate

    is a combination of two medications. Amoxicillin is an antibiotic that fights bacteria, and clavulanate is a substance that helps prevent certain bacteria from becoming resistant to amoxicillin. This combination is used in the trial to treat community-acquired pneumonia in older patients, and the study aims to compare its effectiveness to amoxicillin alone.

What is already known about the treatment

  • Amoxicillin

    Amoxicillin is an antibiotic that is usually taken orally in the form of a pill or liquid. It is currently well-established in medical practice and literature as a treatment for bacterial infections. The main use of amoxicillin is to treat infections like pneumonia, especially in older adults who are hospitalized but not in intensive care. It works by stopping bacteria from building their cell walls, which kills the bacteria. Amoxicillin is classified as a narrow-spectrum antibiotic, meaning it targets specific types of bacteria.

  • Amoxicillin/Clavulanate

    Amoxicillin/Clavulanate is a combination antibiotic taken orally, typically as a pill or liquid. It is widely used in medicine to treat various bacterial infections. This medication is particularly used for treating pneumonia in older patients who are hospitalized but not in intensive care. The amoxicillin part works by preventing bacteria from forming cell walls, while clavulanate helps by stopping bacteria from breaking down the antibiotic, making it more effective. It is classified as a broad-spectrum antibiotic, meaning it can target a wider range of bacteria.

Investigated diseases

Community-Acquired Pneumonia – Community-acquired pneumonia is an infection of the lungs acquired outside of a hospital setting. It typically begins when bacteria, viruses, or fungi enter the lungs and cause inflammation. The disease progresses with symptoms such as cough, fever, chills, and difficulty breathing. As the infection advances, patients may experience chest pain, fatigue, and production of phlegm. In severe cases, the infection can spread to the bloodstream or other parts of the body. The progression and severity of symptoms can vary based on the individual's age, overall health, and the specific pathogen causing the infection.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-503645-63-00Protocol codeRC20_0015Estimated enrolment326 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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