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

Condition(s) studied

Investigational drug(s) / intervention(s)

Meropenem plus vaborbactam: Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g

Study summary

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.

Eligibility

Primary outcome measure(s)

• Area under the concentration-time curve (AUC) for Meropenem — Day 3
• Area under the concentration-time curve (AUC) for Vaborbactam — Day 3
• Maximum plasma concentration (Cmax) for Meropenem — Day 3
• Maximum plasma concentration (Cmax) for Vaborbactam — Day 3
• Clearance (CL) of Meropenem — Day 3
• Clearance (CL) of Vaborbactam — Day 3
• Half-life (t1/2) of Meropenem — Day 3
• Half-life (t1/2) of Vaborbactam — Day 3
• Steady-state volume of distribution (Vss) of Meropenem — Day 3
• Steady-state volume of distribution (Vss) of Vaborbactam — Day 3

Trial sites (22)

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