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Can we predict superbug evolution in the ICU?

NCT ID NCT07744321

Knowledge-focused Sponsor: University Hospital, Caen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study follows intensive care unit (ICU) patients over at least 28 days to see how two types of bacteria—Klebsiella pneumoniae and Enterobacter cloacae—change and evolve in their gut. By analyzing weekly stool samples, researchers hope to understand how these bacteria become more dangerous or resistant to drugs over time. The goal is to gather knowledge that could help hospitals better detect and prevent infections 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.

What this could lead to
If successful, this research could improve how hospitals detect and track dangerous, drug-resistant bacteria in intensive care patients, potentially leading to better infection control strategies.
What could go wrong
This is a small, observational study with only 20 participants, so findings may not apply broadly. It does not test a treatment, so it won't directly change patient care.

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

About 20 people

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

Started

Jan 2023

Expected to finish

Jan 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.

Who is studied

Long-term hospitalized patients (≥ 28 days and 4 swabs) in the surgical and medical ICU departments of the CHU de CAEN and potentially, depending on the course of care, in the neurosurgery department of the CHU de CAEN.

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: * Patient ≥18 years old. * Hospitalization in medical and / or surgical ICU of a duration greater than or equal to 28 days and the production of 4 rectal swabs. * Absence of hospitalization in the last 4 months before inclusion * French speaking patient * Patient affiliated to the social security system * Patient having received an informed opinion on the study and collection of the non-opposition to the latter * Person of trust or family member who has received an informed opinion on the study and the collection of non-opposition to the latter when the patient is judged as incapable of expressing his non-opposition. Exclusion Criteria: * Pregnant or lactating woman * Hospitalization within 4 months before inclusion * Patient whose hospital stay is \<28 days or rectal swabs less than 4 * Absence of Kpn or ECC in the first rectal sample taken * Patient under guardianship / curatorship * Patient deprived of liberty * Patient under judicial protection * Patient not affiliated to the social security system * Refusal to participate in the study requested by the patient or the designated confidential counselor or a designated family member.

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Conditions

The condition(s) this trial relates to.

Genomic Instability Klebsiella infectious disease

As listed by the trial registrant

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

Enterobacter cloacae infection Genomic stability Intensive care unit Klebsiella infections Longitudinal

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

  • Caen University Hospital

    RECRUITING

    Caen, France

More trials for these conditions

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