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Can a simple inhaled antibiotic stop deadly pneumonia in ventilator patients?

NCT ID NCT07665788

Disease control 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a 5-day course of inhaled amikacin can prevent ventilator-associated pneumonia in critically ill patients who already have a milder airway infection called tracheobronchitis. 250 adults on breathing machines will receive either the drug or a placebo. The goal is to see if the treatment reduces the chance of the infection spreading to the lungs.

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 way to prevent a serious lung infection in critically ill patients on breathing machines.
What could go wrong
This is an early-stage trial with only 250 participants, so results may not apply to all patients. The treatment may not prevent pneumonia and could have side effects like kidney issues or hearing loss.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

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 * Admission to a participating intensive care unit (ICU) * Invasive mechanical ventilation \> 48 hours * First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL * Coverage by the French health insurance system (Social Security) * Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient or, failing that, a family member) or, failing that, inclusion performed by the investigator within the therapeutic window (in such cases, informed consent will be sought by the investigator from the patient, or his or her legally designated representative, whichever is sooner). In all cases, the patient's written informed consent will be obtained as soon as possible. * For woman of childbearing potential: negative pregnancy test result at the time of inclusion Exclusion criteria: * Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay * On-going antimicrobial therapy fpr ventilator-associated pneumonia * Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia) * On-going therapy with intravenous amikacin or another aminoglycoside * Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and/or advanced chronic kidney failure (glomerular filtration rate \<30 mL/min), except in patients under renal replacement therapy * Grade B or C cirrhosis (Child-Pugh classification) * Scheduled extubation within 24h * Prior tracheotomy * Administration of inhaled antibiotics within the 7 preceding days * Known hypersensitivity to amikacin, another aminoglycoside, or any of the excipients * Myasthenia gravis * Contraindication to nebulization * On-going treatment with ataluren * Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship). * Moribund patient * End-of-life decision * Previous inclusion in the present study * Participation to another interventional study * Inability of the patient, or the person providing consent, to understand all aspects of the research * Patient being a relative of the investigator or a relative of someone from the team directly involved in the trial, including doctors and pharmacists

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Conditions

The condition(s) this trial relates to.

nosocomial infection Pneumonia, Ventilator-Associated tracheobronchitis

As listed by the trial registrant

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

Ventilator associated pneumonia Ventilator associated tracheobronchitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 01 - ORLEANS - Intensive care, University Hospital

    Orléans, 45000, France

  • 02 - TOURS - Intensive care, University Hospital

    Tours, 37044, France

  • 03 - STRASBOURG - Intensive care, University Hospital

    Strasbourg, 67091, France

  • 04 - ARGENTEUIL - Intensive care, University Hospital

    Argenteuil, France

  • 05 - LE MANS - Intensive care, University Hospital

    Le Mans, 72037, France

  • 06 - ANGERS - Intensive care, University Hospital

    Angers, 49933, France

  • 07 - DIEPPE - Intensive care, University Hospital

    Dieppe, 76202, France

  • 08 - DIJON - Intensive care, University Hospital

    Dijon, 21000, France

  • 09 - BOURG-EN-BRESSE, Intensive care, Hospital

    Bourg-en-Bresse, 01012, France

  • 10 - HENRI MONDOR, Intensive care, University Hospital

    Créteil, 94010, France

  • 11 - BLOIS, Intensive care, Hospital

    Blois, France

  • 12 - DREUX, Intensive care, Hospital

    Dreux, 28100, France

  • 13 - BICHAT, Intensive care, Univerity Hospital

    Paris, France

  • 14 - VERSAILLES, Intensive care, Hospital

    Le Chesnay, 78150, France

  • 15 - LYON EH, Intensive care, University Hospital

    Lyon, 69437, France

  • 16 - LYON SUD, Intensive care, University Hospital

    Pierre-Bénite, 69495, France

  • 17 - LOUIS MOURIER, Intensive care, University Hospital

    Paris, 32700, France

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