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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g
Fakultni nemocnice Ostrava
Ostrava, Czechia
TERMINATEDFaculty Hospital Kralovske Vinohrady, Paediatric Clinic
Prague, Czechia
TERMINATEDHôpital mère-enfant - CHU de Nantes
Nantes, France
RECRUITINGNice University Hospital (CHU de Nice)
Nice, France
RECRUITINGHospital Armand Trousseau Clinical Research Site
Paris, France
TERMINATEDHôpital Robert Debré
Paris, France
RECRUITINGCHRU de Tours Hôpital Clocheville Clinical Research Site
Tours, France
TERMINATEDPoliclinico di Bari
Bari, Italy
RECRUITINGOspedale Sant'Orsola
Bologna, Italy
RECRUITINGGiannina Gaslini Institute
Genoa, Italy
TERMINATED...and 12 more locations
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
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)
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