Study of Aztreonam-Avibactam for Adults in China with MBL-Producing Carbapenem-Resistant Enterobacterales Infections Observing Real-World Treatment Outcomes and Hospital Impact

What this Trial Is About

Researchers are evaluating the real-world use of a new antibiotic combination called Aztreonam-Avibactam ATM-AVI in adult patients hospitalized in China with infections caused by metallo-b2-lactamase-producing carbapenem-resistant Enterobacterales MBL-producing CRE. These infections are resistant to common antibiotics, making them hard to treat. The study aims to understand how well ATM-AVI works outside of initial testing, including its effectiveness, patient characteristics, and impact on hospital stays. This observational study will include about 100 adult patients from around 30 hospitals in China who have been treated with ATM-AVI for at least 24 hours. The study will gather data both retrospectively from past patient records and prospectively with patient consent. Researchers will review how the drug was used and collect information about the infections and patient outcomes at different time points. Participants medical records will be examined to gather details such as patient demographics, infection type, treatment timing, laboratory test results, and hospital resource use. Doctors will assess patient progress after 5 days of treatment, at the end of treatment, and during a follow-up visit to determine if the infection has cleared. The study will also monitor clinical success or failure and any deaths during or after treatment. The study runs from December 2025 to July 2027.

Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE