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

NCT06828848 | Recruiting Phase 2 DMC

• 2 other identifiers: VABOR-KIDS-012024-514656-32-00
• Study Type: interventional
• Target: 44
• Locations: 5 countries
• Sites: 22

Brief 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.

Conditions

Gram Negative Infections

Keywords

pediatric; meropenem; vaborbactam; vaborem; gram negative infection; neonate

Outcome Measures

Primary Outcomes (10)

• Area under the concentration-time curve (AUC) for Meropenem

  Day 3

• Area under the concentration-time curve (AUC) for Vaborbactam

  Day 3

• Maximum plasma concentration (Cmax) for Meropenem

  Day 3

• Maximum plasma concentration (Cmax) for Vaborbactam

  Day 3

• Clearance (CL) of Meropenem

  Day 3

• Clearance (CL) of Vaborbactam

  Day 3

• Half-life (t1/2) of Meropenem

  Day 3

• Half-life (t1/2) of Vaborbactam

  Day 3

• Steady-state volume of distribution (Vss) of Meropenem

  Day 3

• Steady-state volume of distribution (Vss) of Vaborbactam

  Day 3

Secondary Outcomes (1)

• Number of patients experiencing Treatment Emergent Adverse Events (TEAE)

  From baseline (day 1) to the last follow up visit (up to day 30)

Study Arms (1)

Investigational product arm

EXPERIMENTAL

Single arm study. All participants enrolled will receive the investigational product.

Drug: Meropenem plus vaborbactam

Interventions

Meropenem plus vaborbactam DRUG

Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g

Investigational product arm

Eligibility Criteria

• Age: 0 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (22)

Fakultni nemocnice Ostrava

Ostrava, Czechia

RECRUITING

Faculty Hospital Kralovske Vinohrady, Paediatric Clinic

Prague, Czechia

RECRUITING

Hôpital mère-enfant - CHU de Nantes

Nantes, France

RECRUITING

Nice University Hospital (CHU de Nice)

Nice, France

RECRUITING

Hospital Armand Trousseau Clinical Research Site

Paris, France

RECRUITING

Hôpital Robert Debré

Paris, France

RECRUITING

CHRU de Tours Hôpital Clocheville Clinical Research Site

Tours, France

RECRUITING

Policlinico di Bari

Bari, Italy

RECRUITING

Ospedale Sant'Orsola

Bologna, Italy

RECRUITING

Giannina Gaslini Institute

Genoa, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù

Rome, Italy

RECRUITING

Ospedale Regina Margherita

Torino, Italy

RECRUITING

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

Lodz, Poland

WITHDRAWN

Uniwersyteckie Centrum Kliniczne WUM

Warsaw, Poland

RECRUITING

Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

Warsaw, Poland

RECRUITING

Hospital Sant Joan de Deu

Barcelona, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital Dr Josep Trueta

Girona, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Spain

RECRUITING

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

RECRUITING

MeSH Terms

Interventions

Meropenem; vaborbactam

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Monica Bertolotti, Medical Doctor

CONTACT

+39 055 56809922; vabor-kids@menarini-ricerche.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 14, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-09

Locations

ES (6); FR (5); IT (6); PL (3); CZ (2)