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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Area under the concentration-time curve (AUC) for Meropenem
Timeframe: Day 3
Area under the concentration-time curve (AUC) for Vaborbactam
Timeframe: Day 3
Maximum plasma concentration (Cmax) for Meropenem
Timeframe: Day 3
Maximum plasma concentration (Cmax) for Vaborbactam
Timeframe: Day 3
Clearance (CL) of Meropenem
Timeframe: Day 3
Clearance (CL) of Vaborbactam
Timeframe: Day 3
Half-life (t1/2) of Meropenem
Timeframe: Day 3
Half-life (t1/2) of Vaborbactam
Timeframe: Day 3
Steady-state volume of distribution (Vss) of Meropenem
Monica Bertolotti, Medical Doctor
Timeframe: Day 3
Steady-state volume of distribution (Vss) of Vaborbactam
Timeframe: Day 3