A MULTICENTER, OPEN-LABEL, PHASE 1B STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SULBACTAM-DURLOBACTAM IN HOSPITALIZED PEDIATRIC PATIENTS FROM BIRTH TO <18 YEARS WHO ARE RECEIVING SYSTEMIC ANTIBIOTIC THERAPY FOR SUSPECTED OR CONFIRMED ACINETOBACTER BAUMANNII-CALCOACETICUS COMPLEX INFECTION

This study is testing the safety and behavior of a new antibiotic combination called sulbactam-durlobactam (SUL-DUR) in babies and children who are in the hospital with serious infections caused by a bacteria called Acinetobacter baumannii. This bacteria can be very hard to treat because it resists many common antibiotics. SUL-DUR has already been approved for use in adults, but it has never been tested in children before. The study will include children from 7 days old up to 18 years old who are already receiving antibiotics for a suspected or confirmed Acinetobacter infection. Doctors will give SUL-DUR through an IV and collect blood samples to see how the medicine moves through the child?s body and whether it causes any side effects. The goal is to find the right dose for children of different ages. Although this study does not aim to prove whether the drug cures infections, it helps determine if the drug is safe for kids and how much should be given. The entire study is expected to take about five years and will involve around 48 children in hospitals across different countries

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