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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

RecruitingPhase 2Ages 0 Months - 17 YearsAllMenarini Group
NCT06828848 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Meropenem plus vaborbactam
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Where

22 sites
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

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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