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Early antibiotics in ICU aspiration: small trial halted before answers

NCT ID NCT05079620

Disease control Sponsor: UConn Health 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 antibiotics early to ICU patients who may have inhaled stomach contents could prevent pneumonia and improve recovery. Only 5 patients were enrolled before the trial was stopped early. The results are too limited to draw any conclusions about whether this approach works.

What this could mean

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

Active substance
Ceftriaxone, amoxicillin/clavulanic acid, or cefepime (antibiotics)
What this could lead to
If it had succeeded, this could have pointed to a standard approach for using early antibiotics to prevent pneumonia in ICU patients after aspiration.
What could go wrong
The trial was terminated early with only 5 participants, so results are very limited. It is unclear if early antibiotics help or harm in this setting, and overuse of antibiotics carries risks like resistance and side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

5 people

The number who actually took part.

Started

Nov 2021

Finished

Apr 2024

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: * Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU * Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris) * Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event). Exclusion Criteria: * Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment * Requires antibiotic therapy for the treatment of other infections * Patient "comfort measures only" at time of screening * Currently participating in other trials using investigational drugs or interventions * Currently pregnant * Currently a prisoner * The consenting party (patient or their legally authorized representative) is unable to understand or read English at a fifth-grade level. * 2 or more of the following are present at the time of screening: * White blood cell count: ≥ 11.0 * Temperature ≥ 38.0C (100.4F) * Purulent secretions * S/F (pulse oximetry saturation to FiO2) ratio ≤ 215

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Conditions

The condition(s) this trial relates to.

aspiration pneumonia aspiration pneumonitis Pneumonia, Ventilator-Associated pneumonia prevention target

As listed by the trial registrant

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

Aspiration Aspiration pneumonia

Contacts and locations

Locations

  • UConn Health, John Dempsey Hospital

    Farmington, Connecticut, 06030, United States

More trials for these conditions

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