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A study testing inhaled amikacin compared to placebo in critically ill patients with ventilator-associated tracheobronchitis

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What is this trial about?

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

This study involves patients who are critically ill and on a breathing machine who have developed ventilator-associated tracheobronchitis, which is an infection of the airways that can occur when a person needs help breathing through a tube in their windpipe for several days. The treatment being tested is amikacin, an antibiotic that will be given through inhalation as a mist directly into the lungs using a special device called a nebulizer, rather than being given through a vein or by mouth as it is normally used. Some patients will receive amikacin while others will receive placebo. The study will also use sodium chloride solution for the preparation of the treatments.

The purpose of the study is to find out whether giving inhaled amikacin for five days can reduce the chance that the airway infection will get worse and turn into ventilator-associated pneumonia, which is a more serious lung infection. The study will compare patients who receive the antibiotic treatment to those who receive placebo to see if there is a difference in how many patients develop this more serious lung infection within 28 days.

During the study, patients will receive either inhaled amikacin or placebo once a day for five days through the nebulizer device that is connected to the breathing machine. Doctors will monitor patients closely to see if the airway infection improves or worsens, how long patients need to stay on the breathing machine, how long they stay in the intensive care unit and hospital, and whether any side effects occur. The study will also look at other outcomes such as survival rates at 28 and 90 days, the amount of other antibiotics needed, whether new infections develop, and the quality of life for patients who survive after 90 days.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be randomly assigned to receive either inhaled amikacin or placebo. A placebo is an inactive substance that looks like the real treatment but contains no active medication.

    Neither you nor your doctors will know which treatment you are receiving. This is called a double-blind study design.

    If you are a woman of childbearing potential, a pregnancy test will be performed at this stage to confirm you are not pregnant.

  2. Step 2

    Treatment period

    You will receive the assigned treatment for 5 days.

    The treatment will be given through inhalation, which means you will breathe in the medication as a mist directly into your lungs through your breathing tube.

    If you are assigned to the amikacin group, you will receive amikacin, an antibiotic medication. The study uses amikacin powder that is prepared as a solution for injection and then administered through inhalation.

    If you are assigned to the placebo group, you will receive an inactive solution that does not contain the antibiotic.

  3. Step 3

    Monitoring during treatment

    Throughout the treatment period, your medical team will monitor your breathing and overall condition closely.

    Samples from your airways may be collected to check for bacteria and to see if the infection is improving.

    Your doctors will watch for any side effects related to the inhaled treatment, particularly any breathing-related reactions.

    Your kidney function will be monitored to check for any signs of kidney injury.

  4. Step 4

    Assessment at day 7

    At day 7 after starting treatment, your medical team will evaluate whether the infection in your airways has progressed to pneumonia.

    Samples from your airways will be taken to check if the bacteria that caused the initial infection are still present.

    Your doctors will assess whether the clinical signs of your airway infection have improved or resolved.

  5. Step 5

    Assessment at day 28

    At day 28, a comprehensive evaluation will be performed.

    Your medical team will determine whether your airway infection progressed to ventilator-associated pneumonia, which is a lung infection that can develop in patients on breathing machines.

    The total time you spent on the breathing machine will be recorded.

    The number of days you were free from the breathing machine will be counted.

    All antibiotics you received during this period will be documented.

    Samples will be taken to check for the presence of multidrug-resistant bacteria in your intestines.

    Your doctors will assess whether you developed any new infections caused by multidrug-resistant bacteria.

    The length of your stay in the intensive care unit and hospital will be recorded.

    Your kidney function will be assessed for any signs of injury.

  6. Step 6

    Assessment at day 90

    At day 90 after starting the study treatment, if you have survived, your health-related quality of life will be evaluated.

    This assessment will help determine how the treatment and your recovery have affected your daily functioning and well-being.

  7. Step 7

    Additional assessments for selected participants

    Some participants will be selected for additional blood sampling to measure the levels of amikacin in the bloodstream.

    This information helps researchers understand how the inhaled medication is absorbed and processed by the body.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older
  • You must be experiencing your first episode of ventilator-associated tracheobronchitis during your stay in the intensive care unit, which is a specialized hospital unit for patients who need close monitoring and support for breathing and other vital functions. Ventilator-associated tracheobronchitis is an infection of the airways that can occur when a patient is on a breathing machine called a ventilator
  • You must have coverage by the French health insurance system
  • You or your legally designated representative must provide written permission to participate in the study. A legally designated representative is someone who can make medical decisions on your behalf if you are unable to do so yourself, such as a trusted person you have chosen or a family member. If this is not possible due to urgent circumstances, the doctor may include you in the study within the necessary treatment time
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the time of joining the study and must use an acceptable method of birth control to prevent pregnancy during the study

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified in the available study information. This means the study documents do not list specific reasons why patients cannot participate beyond the general requirements for enrollment.
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Investigated drugs

  • Amikacin

    is an antibiotic medication that will be given through inhalation (breathed in) to help treat patients who have a breathing tube and have developed an infection in their airways called ventilator-associated tracheobronchitis. The purpose of this medication in the study is to see if it can prevent the infection from getting worse and turning into pneumonia.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against the actual treatment to see if the inhaled amikacin really works.

What is already known about the treatment

Amikacin – Amikacin is an antibiotic medication that belongs to a group called aminoglycosides, which work by stopping bacteria from making proteins they need to survive and grow. In this clinical trial, it is being tested as an inhaled treatment given directly into the lungs through breathing equipment for patients in intensive care who have developed a bacterial infection in their airways called ventilator-associated tracheobronchitis. The study is investigating whether breathing in amikacin for five days can prevent this infection from getting worse and spreading deeper into the lungs to cause pneumonia. This inhaled form allows the medication to reach high concentrations directly at the site of infection in the airways while potentially reducing side effects that might occur with injected antibiotics.

Investigated diseases

  • Ventilator-Associated Tracheobronchitis

    Ventilator-associated tracheobronchitis is an infection of the windpipe and airways that occurs in patients who are on breathing machines in intensive care units. The condition develops when bacteria enter and infect the lower airways while a person is being supported by a mechanical ventilator. Patients typically show signs of infection such as fever, increased mucus production, and changes in the appearance of secretions from the breathing tube. The infection causes inflammation in the trachea and bronchi, leading to breathing difficulties and increased need for ventilator support. If left unmanaged, this condition can progress to a more serious lung infection. The disease represents an intermediate stage between simple bacterial colonization of the airways and full pneumonia.

  • Ventilator-Associated Pneumonia

    Ventilator-associated pneumonia is a lung infection that develops in patients who are receiving mechanical breathing support in hospitals. This condition occurs when bacteria enter the lungs through the breathing tube and cause infection in the lung tissue itself. The infection typically develops 48 hours or more after a patient has been placed on a ventilator. Patients experience symptoms including fever, difficulty breathing, low oxygen levels, and changes in chest X-rays showing lung infiltrates. The condition causes fluid and inflammatory cells to fill the air sacs in the lungs, making breathing and oxygen exchange more difficult. Ventilator-associated pneumonia can be caused by various bacteria, including those that are resistant to multiple antibiotics.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510075-63-00Protocol codeDR230005Estimated enrolment250 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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