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Study on Amoxicillin and Clavulanic Acid for Treating Ventilator-Associated Pneumonia in Intensive Care Patients

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 Ventilator-Associated Pneumonia (VAP), a type of lung infection that occurs in people who are on mechanical ventilators in intensive care units. The study will use a treatment involving a combination of two substances: amoxicillin and clavulanic acid, which are administered as a solution for injection. These substances work together to fight bacterial infections.

The purpose of the study is to explore whether a specific approach to managing VAP, which includes daily checks to see if the infection has been cured and stopping the antibiotics if it has, is as effective as the usual treatment methods. Participants in the study will receive either the treatment with amoxicillin and clavulanic acid or a placebo. The study will monitor the participants over a period of time to observe outcomes such as survival rates, the recurrence of pneumonia, and any new episodes of VAP.

Throughout the study, researchers will also look at other factors, such as the number of days patients are free from antibiotics, the length of stay in the intensive care unit, and any side effects from the antibiotics. The study aims to provide valuable insights into the best ways to treat VAP in patients who are critically ill and require mechanical ventilation.

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, the patient must meet specific criteria, including being an adult aged 18 or older and having a confirmed diagnosis of the first episode of ventilator-associated pneumonia (VAP).

    The patient must have received initial appropriate antibiotic therapy and provided written informed consent, either personally or through a legal representative if necessary.

  2. Step 2

    Initial treatment

    The patient will receive a medication called amoxicillin/clavulanic acid in the form of a solution for injection.

    This medication is administered intravenously.

  3. Step 3

    Daily assessment

    The patient's condition will be assessed daily to determine clinical improvement and the possibility of discontinuing antibiotics if improvement is observed.

    The goal is to ensure that the treatment is effective without unnecessary continuation of antibiotics.

  4. Step 4

    Monitoring and evaluation

    The primary focus is on evaluating the patient's overall health, including monitoring for any signs of pneumonia within 72 hours after the end of antibiotic therapy.

    The study will also track any new episodes of VAP from 72 hours after the end of treatment to 28 days after starting the VAP antibiotic treatment.

  5. Step 5

    Follow-up period

    The patient will be monitored for a period of 28 days after the initiation of antibiotic therapy to assess various outcomes, including survival, treatment success, and any new infections.

    Additional evaluations will include the duration of mechanical ventilation, length of stay in the intensive care unit, and any side effects related to antibiotics.

Who can join the trial?

15 criteria

  • The patient must be an adult who is at least 18 years old.
  • The patient must have a diagnosis of the first episode of Ventilator Associated Pneumonia (VAP), confirmed by laboratory tests.
  • The patient must have started an appropriate antibiotic treatment, whether it was based on initial guesses or specific tests.
  • The patient or their legal representative must provide written consent to participate. If there is no legal representative, the patient may be included through an emergency procedure.
  • The patient must have a confirmed diagnosis of VAP according to international guidelines, which includes:
  • The patient has been on a mechanical ventilator for more than 48 hours at the time of the test.
  • There is a new lung infection suspected to be caused by bacteria.
  • The patient's ability to breathe has worsened.
  • Within 24 hours before starting antibiotics, the patient must have:
  • Thick, pus-like mucus from the windpipe.
  • At least one of the following:
  • A fever with a body temperature higher than 38.3°C.
  • A low body temperature below 35°C.
  • An abnormal white blood cell count, either higher than 10,000 cells/mm3 or lower than 4,000 cells/mm3.
  • Positive results from a test that measures bacteria in the lower lungs, using samples like bronchoalveolar lavage fluid, a special catheter, or endotracheal aspirate, with specific bacterial count thresholds.

Who cannot join the trial?

5 criteria

  • Patients who are not in an intensive care setting. This means they are not in a special hospital unit where very sick patients are closely monitored and treated.
  • Patients who do not have Ventilator Associated Pneumonia (VAP). This is a lung infection that can occur in people who are on a machine that helps them breathe.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are not part of the specified clinical trial groups. The study may be looking for certain types of patients.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might need special protection or care, such as children, elderly, or those with certain health conditions.
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Investigated drugs

Antimicrobial Stewardship Program is a strategy used in this trial to manage the use of antibiotics for patients with ventilator-associated pneumonia (VAP) in intensive care. The program involves daily assessments to determine if the patient is clinically cured and if antibiotics can be safely discontinued. The goal is to ensure that the use of antibiotics is effective and does not lead to unnecessary prolonged use, which can help prevent antibiotic resistance and reduce side effects.

What is already known about the treatment

Antimicrobial Stewardship Program – This program is not a medication but a strategy used in intensive care settings, particularly for patients with ventilator-associated pneumonia (VAP). It involves the careful management and assessment of antibiotic use to ensure effective treatment while minimizing unnecessary exposure to antibiotics. The program is currently being studied to determine its effectiveness in reducing mortality and treatment failure rates compared to traditional methods. The main therapeutic indication is the management of VAP in intensive care units. The mechanism of action involves daily evaluation of clinical outcomes to decide whether to continue or discontinue antibiotics, aiming to optimize patient care and reduce antibiotic resistance. This approach falls under the pharmacological classification of antimicrobial management strategies.

Investigated diseases

Ventilator-Associated Pneumonia – This is a lung infection that occurs in people who are on mechanical ventilation through an endotracheal or tracheostomy tube for at least 48 hours. It is characterized by the presence of new or progressive infiltrates on chest X-rays, along with clinical signs such as fever, purulent sputum, and leukocytosis. The condition develops when bacteria enter the lower respiratory tract, often due to the presence of the ventilator tube. Over time, the infection can lead to inflammation and fluid accumulation in the lungs, making breathing difficult. The progression of the disease can vary, with some patients experiencing mild symptoms while others may develop severe respiratory distress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513327-16-00Protocol codeAPHP200011Estimated enrolment590 patientsSponsorAssistance Publique Hopitaux De Paris

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