Actively Recruiting
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
Led by Menarini Group · Updated on 2026-02-04
44
Participants Needed
22
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent before starting any study procedures
- Male or female from birth to under 18 years of age
- Requires hospitalization and at least 3 days of intravenous antibiotic treatment for suspected or confirmed Gram negative infection
- Has Gram negative infection diagnosed as complicated urinary tract infection, acute pyelonephritis, complicated intra-abdominal infection, hospital-acquired or ventilator-associated pneumonia, or bloodstream infection
You will not qualify if you...
- History of moderate or significant allergy to beta-lactam antibiotics or any component of the study drug
- Infection unlikely to respond to the study treatment according to the investigator
- Currently receiving immunosuppressive agents, valproic acid, or probenecid
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Fakultni nemocnice Ostrava
Ostrava, Czechia
Actively Recruiting
2
Faculty Hospital Kralovske Vinohrady, Paediatric Clinic
Prague, Czechia
Actively Recruiting
3
Hôpital mère-enfant - CHU de Nantes
Nantes, France
Actively Recruiting
4
Nice University Hospital (CHU de Nice)
Nice, France
Actively Recruiting
5
Hospital Armand Trousseau Clinical Research Site
Paris, France
Actively Recruiting
6
Hôpital Robert Debré
Paris, France
Actively Recruiting
7
CHRU de Tours Hôpital Clocheville Clinical Research Site
Tours, France
Actively Recruiting
8
Policlinico di Bari
Bari, Italy
Actively Recruiting
9
Ospedale Sant'Orsola
Bologna, Italy
Actively Recruiting
10
Giannina Gaslini Institute
Genoa, Italy
Actively Recruiting
11
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Actively Recruiting
12
Ospedale Pediatrico Bambino Gesù
Rome, Italy
Actively Recruiting
13
Ospedale Regina Margherita
Torino, Italy
Actively Recruiting
14
Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)
Lodz, Poland
Withdrawn
15
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Poland
Actively Recruiting
16
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland
Actively Recruiting
17
Hospital Sant Joan de Deu
Barcelona, Spain
Actively Recruiting
18
Hospital Universitario Puerta del Mar
Cadiz, Spain
Actively Recruiting
19
Hospital Dr Josep Trueta
Girona, Spain
Actively Recruiting
20
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Actively Recruiting
21
Hospital Regional Universitario de Málaga
Málaga, Spain
Actively Recruiting
22
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Actively Recruiting
Research Team
M
Monica Bertolotti, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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