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Breathing easy: inhaled antibiotic may stop ventilator pneumonia

NCT ID NCT03149640

Prevention Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving inhaled amikacin for three days could prevent pneumonia in 850 adults on breathing machines. Patients received either the drug or a placebo starting day 4 of ventilation. The goal was to see if the treatment reduced pneumonia cases up to day 28.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inhaled amikacin
What this could lead to
If it works, this could offer a simple way to prevent pneumonia in patients on breathing machines, reducing illness and antibiotic use.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all ICU settings. Inhaled antibiotics can cause airway irritation or resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

850 people

The number who actually took part.

Started

Jul 2017

Finished

Jun 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years the day of inclusion * Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h) * Written informed consent of the patient or a proxy * Patients covered by or having the rights to French social security * Negative pregnancy test, at the time of inclusion, in women of childbearing potential Exclusion Criteria: * Suspicion or confirmed VAP the day of inclusion * Clinical indication for systemic aminoglycoside therapy the day of inclusion : as deemed necessary by the clinician in charge * Stage 2 or 3 KDIGO\* classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy * Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min * Patient scheduled for extubation within the next 24h * Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h) * Patient ventilated through a tracheostomy * Patients allergic to aminoglycosides * Myasthenia gravis * Known pregnant women at the time of inclusion and lactating patients * Known guardianship or trusteeship at the time of inclusion * Patients previously included in this study

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Conditions

The condition(s) this trial relates to.

Pneumonia, Ventilator-Associated

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumonia, ventilator-associated

Contacts and locations

Locations

  • Service de Réanimation

    Dijon, 21079, France

  • Service de Réanimation

    Le Mans, 72037, France

  • Service de Réanimation - NHC

    Strasbourg, 67091, France

  • Service de Réanimation Chirurgicale

    Angers, 49933, France

  • Service de Réanimation Médicale

    Orléans, 45100, France

  • Service de Réanimation Médicale

    Poitiers, 86021, France

  • Service de Réanimation Médicale - CH d'Angoulême

    Angoulême, 16959, France

  • Service de Réanimation Médicale - CHD Les Oudairies

    La Roche-sur-Yon, 85025, France

  • Service de Réanimation Médicale - CHU La Milétrie

    Poitiers, 86021, France

  • Service de Réanimation Médicale - CHU Pontchaillou

    Rennes, 35033, France

  • Service de Réanimation Médicale - CHU Rouen

    Rouen, 76031, France

  • Service de Réanimation Médicale - Hôpital Charles Nicolle

    Rouen, 76031, France

  • Service de Réanimation Médicale - Hôpital La Croix-Rousse

    Lyon, 69317, France

  • Service de Réanimation Médicale - Hôpital Louis Mourier

    Colombes, 92700, France

  • Service de Réanimation Médicale - Hôpital Pitié Salpêtrière

    Paris, 75013, France

  • Service de Réanimation Médicale - Hôpital de Hautepierre

    Strasbourg, 67098, France

  • Service de Réanimation Polyvalente

    Argenteuil, France

  • Service de Réanimation médicale, Hôpital Trousseau

    Tours, 37044, France

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