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

February 3, 2026 updated by: Menarini Group

An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Ostrava, Czechia
        • Recruiting
        • Fakultni Nemocnice Ostrava
        • Contact:
      • Prague, Czechia
        • Recruiting
        • Faculty Hospital Kralovske Vinohrady, Paediatric Clinic
        • Contact:
  • France
      • Nantes, France
        • Recruiting
        • Hôpital mère-enfant - CHU de Nantes
        • Contact:
      • Nice, France
        • Recruiting
        • Nice University Hospital (CHU de Nice)
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Robert Debré
        • Contact:
      • Paris, France
        • Recruiting
        • Hospital Armand Trousseau Clinical Research Site
        • Contact:
      • Tours, France
        • Recruiting
        • CHRU de Tours Hôpital Clocheville Clinical Research Site
        • Contact:
  • Italy
      • Bari, Italy
      • Bologna, Italy
        • Recruiting
        • Ospedale Sant'Orsola
        • Contact:
      • Genoa, Italy
        • Recruiting
        • Giannina Gaslini Institute
        • Contact:
      • Parma, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Parma
        • Contact:
      • Rome, Italy
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Contact:
      • Torino, Italy
        • Recruiting
        • Ospedale Regina Margherita
        • Contact:
  • Poland
      • Lodz, Poland
        • Withdrawn
        • Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)
      • Warsaw, Poland
        • Recruiting
        • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne WUM
        • Contact:
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Sant Joan de Déu
        • Contact:
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
      • Girona, Spain
        • Recruiting
        • Hospital Dr Josep Trueta
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Málaga, Spain
      • Santiago de Compostela, Spain
        • Recruiting
        • Hospital Clínico Universitario de Santiago de Compostela
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational product arm
Single arm study. All participants enrolled will receive the investigational product.
Drug: Meropenem plus vaborbactam
Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) for Meropenem
Time Frame: Day 3
Day 3
Area under the concentration-time curve (AUC) for Vaborbactam
Time Frame: Day 3
Day 3
Maximum plasma concentration (Cmax) for Meropenem
Time Frame: Day 3
Day 3
Maximum plasma concentration (Cmax) for Vaborbactam
Time Frame: Day 3
Day 3
Clearance (CL) of Meropenem
Time Frame: Day 3
Day 3
Clearance (CL) of Vaborbactam
Time Frame: Day 3
Day 3
Half-life (t1/2) of Meropenem
Time Frame: Day 3
Day 3
Half-life (t1/2) of Vaborbactam
Time Frame: Day 3
Day 3
Steady-state volume of distribution (Vss) of Meropenem
Time Frame: Day 3
Day 3
Steady-state volume of distribution (Vss) of Vaborbactam
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients experiencing Treatment Emergent Adverse Events (TEAE)
Time Frame: From baseline (day 1) to the last follow up visit (up to day 30)
From baseline (day 1) to the last follow up visit (up to day 30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VABOR-KIDS-01
  • 2024-514656-32-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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