MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-04

No results posted yet for this 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.

Conditions

  • Gram Negative Infections

Interventions

DRUG

Meropenem plus vaborbactam

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

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-18
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Czechia
  • France
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828848 on ClinicalTrials.gov