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Study on Early Stopping of Antibiotics in Elderly Patients with Viral Infections Using Amoxicillin, Clavulanic Acid, Piperacillin, Tazobactam, and Pristinamycin

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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 elderly patients who are hospitalized due to viral infections. The study aims to explore the benefits of stopping antibiotic treatment early compared to the standard management approach. The antibiotics being studied include Amoxicillin and Beta-Lactamase Inhibitor, Piperacillin and Beta-Lactamase Inhibitor, Pristinamycin, and Ceftriaxone. These medications are commonly used to treat bacterial infections, but the study is investigating their use in cases where a viral infection is present.

The purpose of the study is to determine if stopping antibiotics early in cases of viral pneumonia, which is a type of lung infection, can reduce the overall use of antibiotics after one month. Participants in the study will receive either the standard antibiotic treatment or a placebo, and their progress will be monitored over a period of time. The study will look at various outcomes, including the number of days without antibiotics, any side effects from the antibiotics, and other health complications that may arise during hospitalization.

Throughout the study, participants will be closely observed to ensure their safety and to gather data on the effectiveness of early antibiotic discontinuation. The study will also assess the impact on the duration of hospital stays and overall health outcomes, such as mortality rates and the ability to perform daily activities. The findings from this study could help improve treatment strategies for elderly patients with viral infections, potentially leading to better health outcomes and reduced antibiotic use.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking for signs of a lower respiratory infection, such as fever above 38°C, abnormal white blood cell count, purulent sputum, or lung sounds indicating infection.

    A microbiological diagnostic sample is taken within 48 hours to assist in diagnosis.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to either the early discontinuation group or the standard management group.

    The study aims to evaluate the benefits of stopping antibiotics early in cases of viral pneumonia.

  3. Step 3

    Medication administration

    Depending on the group assignment, participants may receive one of the following antibiotics: amoxicillin and beta-lactamase inhibitor, piperacillin and beta-lactamase inhibitor, pristinamycin, or ceftriaxone.

    These medications are administered through injection, intravenous injection, intravenous infusion, or orally, depending on the specific drug.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for side effects such as diarrhea, nausea, vomiting, or allergic reactions. Any side effects are recorded in an electronic case report form.

    The study also tracks other complications, including hospital-acquired infections, confusion, and mortality rates at one and three months.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is the number of days without antibiotics at 30 days.

    Secondary outcomes include the duration of hospitalization, side effects, and overall health status at one and three months.

Who can join the trial?

8 criteria

  • The patient must be an elderly person who is hospitalized due to a viral infection.
  • The patient must be hospitalized for a lower respiratory infection. This means an infection in the lungs or airways. The infection is defined by having 2 out of these 4 signs:
    • Hyperthermia: A body temperature higher than 38°C (100.4°F).
    • Hyperleukocytosis: A high or low white blood cell count, specifically 12,000 or more, or 4,000 or less. White blood cells are part of the body's defense system.
    • Aspirations/purulent sputum: Coughing up thick mucus that may be yellow or green.
    • Rales on pulmonary auscultation: Crackling sounds heard in the lungs when a doctor listens with a stethoscope, indicating lung tissue involvement.
    • The infection must be associated with a pulmonary image. This means there should be a picture of the lungs, like an X-ray, CT scan, or ultrasound, showing the infection.
    • A microbiological diagnostic sample must be taken within 48 hours of hospitalization. This is a sample taken to identify the cause of the infection.
    • Both male and female patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who are not elderly. This study is only for older adults.
  • Patients who are not hospitalized. The study is for those currently in the hospital.
  • Patients who do not have a viral infection. The study focuses on viral infections.
  • Patients who do not have pneumonia. Pneumonia is an infection that inflames the air sacs in the lungs.
  • Patients who are part of a vulnerable population. This means groups that might need special protection or care.
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Investigated drugs

Antibiotics are medications used to treat bacterial infections. In this clinical trial, they are being studied to see if stopping them early in cases of viral pneumonia can reduce their overall use without harming the patient. Antibiotics are not effective against viruses, but they are often used in cases of pneumonia to prevent or treat secondary bacterial infections. The trial aims to determine if it is safe and beneficial to discontinue antibiotics sooner in elderly patients with viral infections.

What is already known about the treatment

Antibiotic Therapy – This medication is typically administered orally or intravenously, depending on the specific antibiotic and the patient's condition. In the context of the clinical trial, the focus is on elderly patients hospitalized for viral infections, particularly viral pneumonia. The current status in medical literature emphasizes the potential benefits of reducing antibiotic use when not necessary, as overuse can lead to resistance. The main therapeutic indication is to treat bacterial infections, although the trial investigates its use in viral infections to assess the impact of early discontinuation. Antibiotics work by targeting and inhibiting the growth of bacteria, either by disrupting cell wall synthesis or protein production. They are classified pharmacologically as antibacterial agents.

Investigated diseases

Viral Pneumonia – Viral pneumonia is an infection of the lungs caused by a virus. It leads to inflammation in the lung tissue, resulting in symptoms such as cough, fever, and difficulty breathing. The disease progresses as the virus multiplies in the respiratory tract, causing the air sacs in the lungs to fill with fluid or pus. This can lead to reduced oxygen exchange and respiratory distress. The severity of symptoms can vary, with some individuals experiencing mild symptoms while others may have more severe respiratory issues. Recovery time can differ based on the individual's overall health and the specific virus causing the infection.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase ITrial ID2024-515695-13-00Protocol codePI2023_843_0153Estimated enrolment256 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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