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RECRUITINGPhase 2INTERVENTIONAL

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

An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Main Who May Qualify: - Written willing to sign a consent form 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). Main Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Main 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). 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. * 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.

Treatments Being Tested

DRUG

Meropenem plus vaborbactam

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

Locations (20)

Fakultni nemocnice Ostrava
Ostrava, Czechia
Faculty Hospital Kralovske Vinohrady, Paediatric Clinic
Prague, Czechia
Hôpital mère-enfant - CHU de Nantes
Nantes, France
Nice University Hospital (CHU de Nice)
Nice, France
Hospital Armand Trousseau Clinical Research Site
Paris, France
Hôpital Robert Debré
Paris, France
CHRU de Tours Hôpital Clocheville Clinical Research Site
Tours, France
Policlinico di Bari
Bari, Italy
Ospedale Sant'Orsola
Bologna, Italy
Giannina Gaslini Institute
Genoa, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Ospedale Pediatrico Bambino Gesù
Rome, Italy
Ospedale Regina Margherita
Torino, Italy
Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)
Lodz, Poland
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Poland
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland
Hospital Sant Joan de Deu
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Dr Josep Trueta
Girona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain