A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections

Last updated: December 4, 2025
Sponsor: Menarini Group
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Nephritis

Nephropathy

Treatment

Meropenem plus vaborbactam

Clinical Study ID

NCT06828848
VABOR-KIDS-01
2024-514656-32-00
  • Ages < 17
  • All Genders

Study Summary

The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.

All participants will receive Vaborem IV every 8 hours to treat the suspected or confirmed Gram negative infections for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.

Participant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit/s after the completion of the treatment.

Eligibility Criteria

Inclusion

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 forsuspected or confirmed Gram negative infection as per Investigator's judgement.

  • Gram negative infection, according to diagnostic criteria for complicated urinarytract infection/acute pyelonephritis (cUTI/AP), complicated intra-AbdominalInfections (cIAI), Hospital-Acquired Pneumonia/Ventilator Associated Pneumonia (HAP/VAP), Blood-Stream Infection (BSI).

Exclusion

Main Exclusion Criteria:

  • History of any moderate or significant hypersensitivity or allergic reaction tobeta-lactam antibiotics or to any component of the investigational medical product.

  • Gram negative infection that in the opinion of the Investigator is unlikely torespond to the study treatment.

  • In treatment with immunosuppressive agents, valproic acid, or probenecid.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Meropenem plus vaborbactam
Phase: 2
Study Start date:
February 18, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava 3068799,
    Czechia

    Active - Recruiting

  • Faculty Hospital Kralovske Vinohrady, Paediatric Clinic

    Prague,
    Czechia

    Site Not Available

  • Faculty Hospital Kralovske Vinohrady, Paediatric Clinic

    Prague 3067696,
    Czechia

    Active - Recruiting

  • Hôpital mère-enfant - CHU de Nantes

    Nantes,
    France

    Site Not Available

  • Hôpital mère-enfant - CHU de Nantes

    Nantes 2990969,
    France

    Active - Recruiting

  • Nice University Hospital (CHU de Nice)

    Nice,
    France

    Site Not Available

  • Nice University Hospital (CHU de Nice)

    Nice 2990440,
    France

    Active - Recruiting

  • Hospital Armand Trousseau Clinical Research Site

    Paris,
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris,
    France

    Site Not Available

  • Hospital Armand Trousseau Clinical Research Site

    Paris 2988507,
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris 2988507,
    France

    Active - Recruiting

  • CHRU de Tours Hôpital Clocheville Clinical Research Site

    Tours,
    France

    Site Not Available

  • CHRU de Tours Hôpital Clocheville Clinical Research Site

    Tours 2972191,
    France

    Active - Recruiting

  • Policlinico di Bari

    Bari,
    Italy

    Site Not Available

  • Policlinico di Bari

    Bari 3182351,
    Italy

    Active - Recruiting

  • Giannina Gaslini Institute

    Genoa,
    Italy

    Site Not Available

  • Giannina Gaslini Institute

    Genoa 3176219,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Parma

    Parma 3171457,
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Rome,
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Rome 3169070,
    Italy

    Active - Recruiting

  • Ospedale Regina Margherita

    Torino,
    Italy

    Site Not Available

  • Ospedale Regina Margherita

    Torino 8980539,
    Italy

    Active - Recruiting

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

    Lodz 3093133,
    Poland

    Active - Recruiting

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw,
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne WUM

    Warsaw 756135,
    Poland

    Active - Recruiting

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw 756135,
    Poland

    Active - Recruiting

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

    Łódź,
    Poland

    Site Not Available

  • Hospital Sant Joan de Deu

    Barcelona,
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz,
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cadiz 2520600,
    Spain

    Active - Recruiting

  • Hospital Dr Josep Trueta

    Girona,
    Spain

    Site Not Available

  • Hospital Dr Josep Trueta

    Girona 3121456,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Malaga,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga 2514256,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela,
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela 3109642,
    Spain

    Active - Recruiting

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