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Antibiotics fail to show benefit for ventilator lung infection in terminated trial

NCT ID NCT03012360

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether giving antibiotics to ICU patients with a lung infection caused by a breathing tube (ventilator-associated tracheobronchitis) could stop it from turning into pneumonia. About 100 critically ill adults on ventilators took part. The trial was stopped early, and the results did not clearly show that antibiotics helped prevent 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 4

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

Participants

103 people

The number who actually took part.

Started

Feb 2018

Finished

Jul 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: * All adult patients hospitalized in the ICU with a first episode of VAT diagnosed \>48 hours after starting invasive mechanical ventilation are eligible for this study. VAT is defined using the following criteria: 1. absence of new infiltrate on chest X ray 2. two of the three following conditions: fever \> 38.5 °C or \<36.5, leucocyte count \> than 12 000 cells per μL or \<than 4000 cells per μL purulent tracheal secretions 3. and positive tracheal aspirate (≥105 cfu/mL) Exclusion Criteria: * long-term tracheostomy at ICU admission * patients who develop VAP before VAT * patients already receiving antibiotics active against all the microorganisms responsible for VAT * severe immunosuppression * pregnancy or breastfeeding * patients \<18 years * patients already included in another study, with potential interaction with the primary objective of the current study * known resistance to imipenem and ciprofloxacin of bacteria responsible for VAT * treatment limitation decisions * moribund patients (likely to die within 24 h) * allergy to any of study drugs: hypersensitivity to any carbapenem, severe hypersensitivity (for example anaphylactic reaction or severe cutaneous reaction) to any other antibiotic form beta-lactam group (such as penicillin or cephalosporin), severe hypersensitivity (for example anaphylactic reaction) to any other antibiotic from beta-lactam group (penicillin, monobactam or carbapenem), hypersensitivity to quinolones

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Critical illness Mechanical ventilation complication

Contacts and locations

Locations

  • Hôpital Roger Salengro, CHRU

    Lille, France

More trials for these conditions

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