Study of Sulbactam-Durlobactam to Find Safe and Effective Dosing in Hospitalized Children From Birth to Under 18 Years Treating Acinetobacter Baumannii-calcoaceticus Complex Infection

What this Trial Is About

Researchers are evaluating Sulbactam-Durlobactam SUL-DUR in hospitalized pediatric patients from birth to under 18 years old who have suspected or confirmed infections caused by Acinetobacter baumannii-calcoaceticus complex ABC. This phase 1b, open-label study aims to collect pharmacokinetic and safety data to determine appropriate dosing for different pediatric age groups. The study is sponsored by Innoviva Specialty Therapeutics and focuses on understanding how the drugs behave in childrens bodies and their tolerability. The study includes several groups based on age, ranging from birth to less than 18 years. Different dosing regimens of Sulbactam and Durlobactam are given intravenously every 6 to 12 hours depending on the patients age and weight, with specific doses for preterm and term infants. The trial is non-randomized and involves multiple experimental cohorts receiving Sulbactam-Durlobactam at various dosages tailored to their developmental stage. Participants will be monitored closely through blood tests to assess drug levels on days 1 and 3, as well as safety assessments over 28 days. These assessments include liver and kidney function, blood counts, vital signs, and recording any adverse events. The study tracks treatment-related effects and changes in health markers to evaluate safety and drug processing in the body. The total study period involves initial dosing followed by regular monitoring to ensure participant safety and gather thorough data on the treatments effects.

A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection