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New trial aims to stop pneumonia in ventilated kids with nebulized antibiotic

NCT ID NCT06488794

Prevention Sponsor: University Hospital Fattouma Bourguiba 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if giving a nebulized antibiotic (colistimethate sodium) can prevent pneumonia in children who are on breathing machines. About 400 children aged 1 month to 14 years will receive either the drug or a placebo twice daily for up to 7 days. The goal is to see if the treatment reduces the number of children who develop ventilator-associated pneumonia.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 400 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

1 month to 14 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: * Children older than 1 month and younger than 14 years * Patients on invasive mechanical ventilation for more than 48 hours * Informed parental consent Exclusion Criteria: * Suspected or confirmed VAP on the day of inclusion * Indication for systemic colistin therapy before or at enrolment in the study * Plan for extubation within the next 24H * Known allergy to colistin * No parental consent * Tracheostomy * Appearance of allergic clinical manifestations in the days of colistin nebulization * Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin

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Conditions

The condition(s) this trial relates to.

pneumonia Pneumonia, Ventilator-Associated

As listed by the trial registrant

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

Ventilator associated pneumonia

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.