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ICU antibiotics under scrutiny: new study targets hidden brain risks

NCT ID NCT03628300

Knowledge-focused Sponsor: Centre Hospitalier Universitaire, Amiens 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 400 intensive care patients receiving beta-lactam antibiotics to see how often these drugs cause brain-related side effects like confusion or agitation. Researchers measured antibiotic levels in the blood and checked patients' neurological status several times a week. The goal is to better understand and prevent these side effects in critically ill patients.

What this could mean

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

Active substance
beta-lactam antibiotics
What this could lead to
If successful, this could lead to safer dosing guidelines for beta-lactam antibiotics in intensive care, reducing the risk of brain-related side effects.
What could go wrong
This is an observational study, not a treatment trial. It may not produce clear-cut recommendations, and 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.

Participants

400 people

The number who actually took part.

Started

Jan 2017

Finished

Jul 2017

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.

Who is studied

This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.

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: * Patients admitted to the ICU * Treatment initiation by an antibiotic of the beta-lactam class * Beta-lactam therapeutic drug monitoring Exclusion criteria: * Any neurological disorder already present at admission * Patients on mechanical ventilation who presented a neurological disorder before being intubated and sedated

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Conditions

The condition(s) this trial relates to.

acute kidney injury infectious disease with sepsis Sepsis toxic encephalopathy

As listed by the trial registrant

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

Acute kidney injury Beta lactams Critical care Neurotoxicity Sepsis Therapeutic drug monitoring

Contacts and locations

Locations

  • CHU Amiens-Picardie

    Amiens, 80054, France

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