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A mist of antibiotic could stop a deadly ICU infection

NCT ID NCT06819462

Prevention Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether inhaling the antibiotic colistin can prevent ventilator-associated pneumonia in people with acute brain injury who need a breathing machine. Ventilator-associated pneumonia is a common and dangerous infection in the ICU, often caused by drug-resistant bacteria. Researchers will give half the participants inhaled colistin and the other half a saline placebo for three days, then compare how many develop pneumonia within a week.

What this could mean

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

Active substance
Inhaled colistin, an antibiotic delivered as a mist to the lungs
What this could lead to
If it works, this could offer a simple way to prevent a dangerous lung infection in critically ill patients on breathing machines, reducing antibiotic use and hospital stays.
What could go wrong
The trial is early and the drug may not prevent pneumonia. Inhaled colistin can also irritate the airways or cause side effects, and the results may not apply to all ICU patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 444 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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 to 80 years

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: 1. Patients aged more than or equal to 18 years and less than 80 years 2. ABI patients admitted to the ICU, including TBI, intracranial haemorrhage, ischaemic stroke, post-cardiac arrest hypoxic-ischaemic encephalopathy or other acute neurological insults 3. Glasgow Coma Scale (GCS) score ≤12 4. Duration of mechanical ventilation more than or equal to 48 hours at enrolment 5. Written informed consent provided by the participant's legally authorised representative. Exclusion Criteria: 1. patients with suspected or confirmed VAP on the day of enrolment 2. Anticipated extubation within the next 24 hours. 3. Duration of mechanical ventilation exceeding 96 hours prior to enrolment. 4. Patients currently receiving or having recently received (within the preceding 24 hours) polymyxin (administered intravenously and/or via nebulization). 5. Known hypersensitivity to polymyxin. 6. Pregnant or breastfeeding women. 7. Myasthenia gravis. 8. Patient with high risk of death within the first 48h after ICU admission. 9. Advanced-stage solid organ malignancy or hematological malignancy.

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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.

Inha'le'D Ventilator-associated pneumonia (VAP)

How to take part

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

  1. The places running it

    1 site. 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

  • Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China

    RECRUITING

    Nanjing, Jiangsu, China

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