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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meropenem plus vaborbactam.
- Who it may be relevant to
- Registry conditions: Gram Negative Infections. Basic parameters: 0 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia, France, Italy, Poland, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Meropenem plus vaborbactam
Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g
Primary outcome measures
- Area under the concentration-time curve (AUC) for Meropenem [Time frame: Day 3]
- Area under the concentration-time curve (AUC) for Vaborbactam [Time frame: Day 3]
- Maximum plasma concentration (Cmax) for Meropenem [Time frame: Day 3]
- Maximum plasma concentration (Cmax) for Vaborbactam [Time frame: Day 3]
- Clearance (CL) of Meropenem [Time frame: Day 3]
- Clearance (CL) of Vaborbactam [Time frame: Day 3]
- Half-life (t1/2) of Meropenem [Time frame: Day 3]
- Half-life (t1/2) of Vaborbactam [Time frame: Day 3]
- Steady-state volume of distribution (Vss) of Meropenem [Time frame: Day 3]
- Steady-state volume of distribution (Vss) of Vaborbactam [Time frame: Day 3]
Secondary outcome measures (1)
- Number of patients experiencing Treatment Emergent Adverse Events (TEAE) [Time frame: From baseline (day 1) to the last follow up visit (up to day 30)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 6 centers
- Policlinico di Bari — Bari
- Ospedale Sant'Orsola — Bologna
- Giannina Gaslini Institute — Genoa
- Azienda Ospedaliero-Universitaria di Parma — Parma
- Ospedale Pediatrico Bambino Gesù — Rome
- Ospedale Regina Margherita — Torino
Spain · 6 centers
- Hospital Sant Joan de Deu — Barcelona
- Hospital Universitario Puerta del Mar — Cadiz
- Hospital Dr Josep Trueta — Girona
- Hospital General Universitario Gregorio Marañón — Madrid
- Hospital Regional Universitario de Málaga — Málaga
- Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela
France · 5 centers
- Hôpital mère-enfant - CHU de Nantes — Nantes
- Nice University Hospital (CHU de Nice) — Nice
- Hospital Armand Trousseau Clinical Research Site — Paris
- Hôpital Robert Debré — Paris
- CHRU de Tours Hôpital Clocheville Clinical Research Site — Tours
Poland · 3 centers
- Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute — Lodz
- Uniwersyteckie Centrum Kliniczne WUM — Warsaw
- Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy — Warsaw
Czechia · 2 centers
- Fakultni nemocnice Ostrava — Ostrava
- Faculty Hospital Kralovske Vinohrady, Paediatric Clinic — Prague
Identifiers
NCT: NCT06828848 · VABOR-KIDS-01 · 2024-514656-32-00