Phase 2a Study of Aztreonam-Avibactam to Evaluate Safety and Effects in Hospitalized Newborns and Infants Under 9 Months With Gram-Negative Bacterial Infections

What this Trial Is About

Researchers are studying the safety and effects of a medicine combining aztreonam ATM and avibactam AVI to treat infections caused by gram-negative bacteria in newborns and infants up to 9 months old who are hospitalized. This Phase 2a study includes two parts Part A focuses on a single dose, and Part B involves multiple doses, aiming to understand the medicines behavior in the body, safety, and how well it is tolerated. In Part A, hospitalized participants receive a single intravenous infusion of ATM-AVI over 3 hours, with blood samples taken during and after the infusion to study pharmacokinetics and safety. Part B participants receive multiple intravenous infusions every 6 to 8 hours for 3 to 14 days to treat suspected or confirmed infections and assess safety, pharmacokinetics, tolerability, and efficacy. Those with certain infections may also receive additional antibiotics, and participants with good responses may switch to oral antibiotics. The study includes 4 age cohorts and excludes overlapping participation between parts. Participants undergo blood level assessments, clinical evaluations at treatment end and test-of-cure visits, and safety monitoring up to 4 to 5 weeks after treatment. Researchers track adverse events, drug concentrations, and clinical outcomes. An independent committee oversees safety data. The total participation time is about 5 weeks for Part A and up to 7 weeks for Part B.

A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)