Condition: Gram Negative Infections · Sponsor: Menarini Group
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.
This description comes directly from the study's public registry record.
Monica Bertolotti, Medical Doctor · +39 055 56809922 · vabor-kids@menarini-ricerche.it
Always discuss trial participation with your own doctor first.
| Fakultni nemocnice Ostrava | Ostrava, Czechia | Recruiting |
| Faculty Hospital Kralovske Vinohrady, Paediatric Clinic | Prague, Czechia | Recruiting |
| Hôpital mère-enfant - CHU de Nantes | Nantes, France | Recruiting |
| Nice University Hospital (CHU de Nice) | Nice, France | Recruiting |
| Hospital Armand Trousseau Clinical Research Site | Paris, France | Recruiting |
| Hôpital Robert Debré | Paris, France | Recruiting |
| CHRU de Tours Hôpital Clocheville Clinical Research Site | Tours, France | Recruiting |
| Policlinico di Bari | Bari, Italy | Recruiting |
| Ospedale Sant'Orsola | Bologna, Italy | Recruiting |
| Giannina Gaslini Institute | Genoa, Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Parma | Parma, Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù | Rome, Italy | Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06828848