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
Recruiting now · Phase 2
Conditions studied: Gram Negative Infections
In brief
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.
Key facts
- Study ID
- NCT06828848
- Run by
- Menarini Group
- People needed
- 44
- Starts
- 2025-02-18
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Uniwersyteckie Centrum Kliniczne WUM — Warsaw, Poland (enrolling)
- Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy — Warsaw, Poland (enrolling)
- Hospital Sant Joan de Deu — Barcelona, Spain (enrolling)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (enrolling)
- Hospital Dr Josep Trueta — Girona, Spain (enrolling)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (enrolling)
- Nice University Hospital (CHU de Nice) — Nice, France (enrolling)
- Policlinico di Bari — Bari, Italy (enrolling)
- Ospedale Sant'Orsola — Bologna, Italy (enrolling)
- Hôpital mère-enfant - CHU de Nantes — Nantes, France (enrolling)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (enrolling)
- Ospedale Pediatrico Bambino Gesù — Rome, Italy (enrolling)
- Ospedale Regina Margherita — Torino, Italy (enrolling)
- Hôpital Robert Debré — Paris, France (enrolling)
- Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela, Spain
- Faculty Hospital Kralovske Vinohrady, Paediatric Clinic — Prague, Czechia
- Hospital Armand Trousseau Clinical Research Site — Paris, France
- CHRU de Tours Hôpital Clocheville Clinical Research Site — Tours, France
- Giannina Gaslini Institute — Genoa, Italy
- Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP) — Lodz, Poland
- Hospital Regional Universitario de Málaga — Málaga, Spain
- Fakultni nemocnice Ostrava — Ostrava, Czechia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.