An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Vaborem (Meropenem-Vaborbactam) in Children With Suspected or Confirmed Gram Negative Infections

What this Trial Is About

Researchers are evaluating how the drug Vaborem, a combination of meropenem and vaborbactam, is processed in the body and how safe and tolerable it is for children from birth up to 18 years old who have suspected or confirmed Gram negative infections. These infections require hospital care and intravenous antibiotic treatment. The study is designed as an open-label, single-arm trial focusing on pharmacokinetics and safety in this pediatric population. All participants will receive Vaborem intravenously every 8 hours for 10 to 14 days to treat their infections. After at least 3 days of Vaborem treatment, participants may switch to an oral antibiotic if appropriate. Pharmacokinetic samples will be collected after the sixth dose or later. This study does not have a placebo or comparison group, as all participants receive the investigational drug. During hospitalization and follow-up visits after treatment completion, participants' health and treatment effects will be closely monitored. Researchers will measure how much and how quickly the drug and its components appear in the blood, including area under the curve, maximum concentration, clearance, half-life, and volume of distribution on day 3 of treatment. Safety will be assessed by tracking any adverse events up to 30 days after treatment. The study is expected to continue until July 2026.

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