Study to Evaluate Safety, Tolerability, and How Vaborem Meropenem-Vaborbactam Works in Children From Birth to 17 Years With Gram Negative Infections

What this Trial Is About

Researchers are evaluating the pharmacokinetics how the drug moves through the body, safety, and tolerability of Vaborem, a combination of meropenem and vaborbactam, in children from birth to under 18 years old who have suspected or confirmed Gram negative infections requiring hospitalization and intravenous antibiotic treatment. This Phase 2 trial focuses on infections that may include complicated urinary tract infections, intra-abdominal infections, pneumonia, and bloodstream infections. All participants receive Vaborem intravenously every 8 hours for 10 to 14 days. After at least 3 days of Vaborem treatment, they may switch to oral antibiotics if appropriate. Pharmacokinetic samples are collected after participants have received at least 6 doses of Vaborem. This is a single-arm study where all enrolled participants receive the investigational drug. Participants will be monitored throughout their hospital stay and during scheduled follow-up visits after treatment completion. Researchers will assess drug levels in the blood on Day 3 and monitor for any adverse events up to 30 days after starting treatment. Clinical conditions and tolerability will be carefully observed to evaluate the study drugs safety and how the body processes it.

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