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New antibiotic combo vaborem tested in kids for tough infections

NCT ID NCT06828848

Disease control Sponsor: Menarini Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study is testing the safety and how the body handles Vaborem, a combination of two antibiotics (meropenem and vaborbactam), in children from birth to under 18 years old who have serious Gram-negative bacterial infections. All 44 participants will receive the drug intravenously every 8 hours for up to 14 days. The goal is to find the right dose and ensure it is safe for children.

What this could mean

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

Active substance
Vaborem (meropenem plus vaborbactam)
What this could lead to
If this trial works, it could provide a safe and effective antibiotic option for children with serious bacterial infections that are hard to treat.
What could go wrong
This is a small, early-phase study with only 44 children, so results may not apply to all kids. The drug may cause side effects or not work as well as hoped.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

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

Started

Feb 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 months to 17 years

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.

Main Inclusion Criteria: * Written informed consent before initiation of any study-related procedures. * Male or female, from birth to \< 18 years of age, inclusive. * Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement. * Gram negative infection, according to diagnostic criteria for complicated urinary tract infection/acute pyelonephritis (cUTI/AP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia/Ventilator Associated Pneumonia (HAP/VAP), Blood-Stream Infection (BSI). Main Exclusion Criteria: * History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product. * Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment. * In treatment with immunosuppressive agents, valproic acid, or probenecid.

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis gram-negative bacterial infections nosocomial infection

As listed by the trial registrant

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

Gram negative infections

How to take part

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

  1. The places running it

    14 sites in 4 countries. 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 Ospedaliero-Universitaria di Parma

    RECRUITING

    Parma, Italy

  • CHRU de Tours Hôpital Clocheville Clinical Research Site

    TERMINATED

    Tours, France

  • Faculty Hospital Kralovske Vinohrady, Paediatric Clinic

    TERMINATED

    Prague, Czechia

  • Fakultni nemocnice Ostrava

    TERMINATED

    Ostrava, Czechia

  • Giannina Gaslini Institute

    TERMINATED

    Genoa, Italy

  • Hospital Armand Trousseau Clinical Research Site

    TERMINATED

    Paris, France

  • Hospital Clinico Universitario de Santiago de Compostela

    TERMINATED

    Santiago de Compostela, Spain

  • Hospital Dr Josep Trueta

    RECRUITING

    Girona, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Spain

  • Hospital Regional Universitario de Málaga

    TERMINATED

    Málaga, Spain

  • Hospital Sant Joan de Deu

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, Spain

  • Hôpital Robert Debré

    RECRUITING

    Paris, France

  • Hôpital mère-enfant - CHU de Nantes

    RECRUITING

    Nantes, France

  • Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)

    TERMINATED

    Lodz, Poland

  • Nice University Hospital (CHU de Nice)

    RECRUITING

    Nice, France

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Rome, Italy

  • Ospedale Regina Margherita

    RECRUITING

    Torino, Italy

  • Ospedale Sant'Orsola

    RECRUITING

    Bologna, Italy

  • Policlinico di Bari

    RECRUITING

    Bari, Italy

  • Uniwersyteckie Centrum Kliniczne WUM

    RECRUITING

    Warsaw, Poland

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    RECRUITING

    Warsaw, Poland

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