AuthorisedTherapeutic confirmatory (Phase III)Interventional

A multicentre, double-blind, randomized controlled trial of inhaled amikacin versus placebo in critically ill patients with ventilator-associated tracheobronchitis (AMIVAT)

This study is for very unwell patients in intensive care who are on a breathing machine and have a lung infection called tracheobronchitis. We know that these infections can sometimes get worse and become a more serious type of pneumonia. The study aims to find out if giving a common antibiotic, amikacin, directly into the lungs as an inhaled mist can help prevent this. We are comparing it to a 'dummy' treatment (placebo) to see if it's more effective. We'll be carefully watching how patients respond, how long they need the breathing machine, and if there are any side effects. The goal is to see if this treatment can improve outcomes for these vulnerable patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

250

Start

12 Jan 2026

Patients with ventilator-associated tracheobronchitis

What is this study about?

When patients are very sick in intensive care and need a breathing machine, they can sometimes develop a lung infection. One type of infection is called tracheobronchitis, which means there's inflammation and infection in the main airways of the lungs. This can sometimes get much worse and turn into a more serious condition called pneumonia.

This study is trying to find a better way to treat tracheobronchitis and prevent it from becoming pneumonia. We are testing a treatment called amikacin, which is an antibiotic that helps fight bacteria. Instead of giving it through a drip, we're giving it as a mist that patients breathe directly into their lungs. This might mean the medicine gets right to where it's needed with fewer side effects.

Patients taking part will be randomly put into two groups. One group will receive the inhaled amikacin, and the other will receive a 'dummy' treatment (a placebo) which looks and feels the same but contains no medicine. This helps us fairly compare if amikacin is truly making a difference. Researchers will look closely at several things, like whether the infection gets worse, how quickly patients get better, and how long they need the breathing machine.

Key takeaways

This study is for very sick adults on breathing machines with a lung infection.
It tests an inhaled antibiotic (amikacin) against a dummy treatment.
The main aim is to see if the inhaled antibiotic stops the infection from getting worse.
Patients' recovery and safety will be closely monitored.
Participation could help find better treatments for future patients.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in intensive care and need help from a breathing machine. To be considered, patients must have a specific lung infection called ventilator-associated tracheobronchitis (VAT).

Doctors will carefully check each patient's medical history and current health to make sure that taking part in this study is safe and appropriate for them. They will ensure that patients meet all the necessary medical criteria for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care?
Are you on a breathing machine?
Do you have a specific lung infection called ventilator-associated tracheobronchitis (VAT)?

Answer every question to see your result.

What does participation involve?

If you or your loved one takes part in this study, they will receive either the inhaled study medicine (amikacin) or a dummy treatment (placebo) for a certain period. This will be given directly into the lungs through the breathing machine. Doctors and nurses will check the patient very regularly, closely monitoring their breathing, general health, and how the infection is progressing.

There will be checks like blood tests and samples from the lungs to see how the treatment is working and to monitor for any side effects. Researchers will also keep track of things like how long the breathing machine is needed, overall time spent in intensive care and hospital, and their health outcomes over several weeks and months. The total duration of follow-up for health information would be up to 90 days after treatment starts.

Potential risks and benefits

Patients who take part in this study might benefit if the inhaled amikacin helps prevent their lung infection from getting worse or improves their recovery. However, there's no guarantee the treatment will work, or that it will be better than standard care. As with any medicine, there's a chance of side effects from amikacin, even when inhaled. Doctors will be monitoring very closely for any potential issues, particularly with kidney function or breathing. Patients or their legal representatives are always free to withdraw from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is tracheobronchitis?

It's an infection and swelling in the main breathing tubes of the lungs, often seen in patients on breathing machines.

What is a 'breathing machine'?

It's a machine that helps patients breathe when they are too sick to do it on their own, often used in intensive care.

What does 'inhaled amikacin' mean?

It means the antibiotic medicine, amikacin, is turned into a fine mist and breathed directly into the lungs.

What is a 'placebo'?

It's a dummy treatment that looks and is given like the real medicine but contains no active ingredients. It helps us see if the real medicine works.

Who is funding this study?

The information provided doesn't explicitly state the funding source, but clinical trials are typically funded by pharmaceutical companies, government bodies, or research institutions.