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A Study to Assess How Vaborem...

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: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gram Negative Infections

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational product arm

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

Group Type EXPERIMENTAL

Meropenem plus vaborbactam

Intervention Type DRUG

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

Interventions

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Meropenem plus vaborbactam

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

Intervention Type DRUG

Eligibility Criteria

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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).

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.

Minimum Eligible Age

0 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers