Clinical trial NCT06828848: A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Complicated Urinary Tract Infection
Official title: An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Keywords: Complicated urinary tract infection
cUTI
Acute Pyelonephritis
pediatric
meropenem
vaborbactam
vaborem
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 3 months to \< 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration.

All participants will receive Vaborem IV every 8 hours to treat cUTI and/or AP 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 their hospitalization and during scheduled visit/s after the completion of the treatment.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent before initiation of any study-related procedures.
* Male or female, 3 months and \< 18 years of age, inclusive.
* Require hospitalization for cUTI/AP and a minimum of 3 days of IV antibiotic treatment for cUTI/API as per Investigator's judgement.Current or suspected cUTI or AP as indicated by the presence of clinical signs and symptoms, and complicating factors.

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.
* cUTI/AP that in the opinion of the Investigator is unlikely to respond to the study treatment.
* Creatinine clearance \<50 mL/min.
* In treatment with immunosuppressive agents, valproic acid, or probenecid.

Primary outcomes:
measure: Area under the concentration-time curve (AUC) for Meropenem
timeFrame: Day 3
measure: Area under the concentration-time curve (AUC) for Vaborbactam
timeFrame: Day 3
measure: Maximum plasma concentration (Cmax) for Meropenem
timeFrame: Day 3
measure: Maximum plasma concentration (Cmax) for Vaborbactam
timeFrame: Day 3
measure: Clearance (CL) of Meropenem
timeFrame: Day 3
measure: Clearance (CL) of Vaborbactam
timeFrame: Day 3
measure: Half-life (t1/2) of Meropenem
timeFrame: Day 3
measure: Half-life (t1/2) of Vaborbactam
timeFrame: Day 3
measure: Steady-state volume of distribution (Vss) of Meropenem
timeFrame: Day 3
measure: Steady-state volume of distribution (Vss) of Vaborbactam
timeFrame: Day 3
Secondary outcomes:
measure: Number of patients experiencing Treatment Emergent Adverse Events (TEAE)
timeFrame: From baseline (day 1) to the last follow up visit (up to day 30)
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady, Paediatric Clinic
city: Nantes
country: France
facility: Hôpital mère-enfant - CHU de Nantes
city: Nice
country: France
facility: Nice University Hospital (CHU de Nice)
city: Paris
country: France
facility: Hospital Armand Trousseau Clinical Research Site
city: Paris
country: France
facility: Hôpital Robert Debré
city: Tours
country: France
facility: CHRU de Tours Hôpital Clocheville Clinical Research Site
city: Genoa
country: Italy
facility: Giannina Gaslini Institute
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
city: Łódź
country: Poland
facility: Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Girona
country: Spain
facility: Hospital Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
Study officials:
References: