Phase 2a Trial to Evaluate Safety, Pharmacokinetics, and Tolerability of Aztreonam-Avibactam with Metronidazole in Newborns and Infants Under 9 Months With Gram-negative Infections Requiring IV Antibiotics

What this Trial Is About

Researchers are studying the safety and effects of a medicine combining aztreonam and avibactam (ATM-AVI) for treating infections caused by gram-negative bacteria in newborns and infants under 9 months old admitted to hospitals. This Phase 2a study aims to understand how the medicine behaves in the body and how well it is tolerated. It includes hospitalized infants with suspected or confirmed bacterial infections requiring intravenous antibiotics. The study has two parts. In Part A, participants receive a single intravenous infusion of ATM-AVI over three hours to assess safety, tolerability, and drug levels without treating the infection. In Part B, participants receive multiple intravenous infusions every 6 to 8 hours for 3 to 14 days as treatment for their infection, with some also receiving metronidazole or other antibiotics as needed. Blood samples and clinical responses are monitored during and after treatment. Participants will undergo blood tests to measure ATM-AVI levels and safety assessments during treatment and up to 5 weeks after infusion. Clinical responses to treatment are evaluated at the end of intravenous therapy, oral antibiotic switch if applicable, and at a test-of-cure visit 7 to 14 days post-treatment. An independent committee will oversee safety, and the total participation lasts 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)