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Can personalized antibiotics outsmart resistant bacteria in liver transplants?

NCT ID NCT07759453

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether giving liver transplant patients antibiotics tailored to the specific resistant bacteria they carry (CPE) can prevent infections better than standard antibiotics. It involves adults colonized with CPE who are undergoing a liver transplant. Researchers will compare the two approaches to see which reduces early infections and how they affect gut bacteria.

What this could mean

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

Active substance
Targeted antibiotic prophylaxis using ceftazidime-avibactam or meropenem-vaborbactam, chosen based on the specific resistant bacteria each patient carries
What this could lead to
If effective, this approach could reduce dangerous infections after liver transplant in patients carrying resistant bacteria, potentially improving survival and recovery.
What could go wrong
The trial is relatively small and early, and results may not apply to all patients. There are also risks of antibiotic side effects and disruption of gut bacteria.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 168 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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

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: * Adult (≥18 years) patients colonized with Carbapenemase-Producing Enterobacterales (CPE) undergoing liver transplantation (LT) * Informed consent signed by the enrolled patients Exclusion Criteria: * Active infection from any Gram-negative bacteria at the time of LT * High risk of donor-derived CPE infection (e.g., donors known to be colonized or infected with CPE at the time of death, or CPE isolated from donor blood or preservation fluid samples) * Hypersensitivity to the active substance or to any of the excipients * Pregnancy and breastfeeding * Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer. * History of severe immediate hypersensitivity reactions (e.g., anaphylaxis) to beta-lactam agents (e.g., cephalosporins, carbapenems, or monobactams). * Colonization by strains resistant to all Investigational Medicinal Products (IMPs)

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, TO, 10126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI, 56126, Italy

  • Irccs Azienda Ospedaliero-Universitaria Di Bologna

    Bologna, BO, 40138, Italy

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