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Can a new antibiotic combo beat Drug-Resistant urinary infections in the blood?

NCT ID NCT07725848

Disease control Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study is testing whether a new antibiotic combination, cefepime/enmetazobactam, works as well as the best current treatments for complicated urinary tract infections that have spread to the bloodstream. These infections are caused by bacteria resistant to many common antibiotics. Researchers will compare how quickly the infection clears from the blood in patients receiving the new combination versus standard therapy.

What this could mean

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

Active substance
a new antibiotic combination called cefepime/enmetazobactam (FEP/META)
What this could lead to
If effective, this antibiotic combination could offer a new treatment option for hard-to-treat urinary tract infections that have spread to the blood, especially those resistant to multiple drugs.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The antibiotic may not prove superior to existing treatments, and resistance could still develop.

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 200 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

Oct 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.

Who is studied

Adult (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT

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 with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT * Adult population (age ≥ 18 years) * Signed informed consent form Exclusion Criteria: * Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs * Patients with negative blood cultures * Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms) * Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture * Patients treated with inappropriate therapy for more than 48 hours * Patients discharged early without follow-up blood cultures * History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis bacterial urinary tract infection

As listed by the trial registrant

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

Antibiotic resistance Complicated urinary tract infections

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

  • ASST Fatebenefratelli Sacco

    Milan, Italy, 20157, Italy

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi

    Catania, Italy, 95122, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Italy, 40138, Italy

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