Single-Center Real-World Observational Study of Sulbactam-Durlobactam for Carbapenem-Resistant Acinetobacter Baumannii Infections Evaluating Effectiveness, Safety, and Drug Exposure

What this Trial Is About

Researchers are conducting a real-world observational study to evaluate the effectiveness and safety of sulbactam-durlobactam in adults hospitalized with carbapenem-resistant Acinetobacter baumannii (CRAB) infections. This study compares patients treated with sulbactam-durlobactam to those receiving other anti-CRAB regimens, focusing on high-risk groups such as transplant recipients and critically ill patients. The goal is to assess outcomes like mortality and clinical failure while addressing biases typically found in observational studies. Patients are grouped based on their treatment: those receiving sulbactam-durlobactam within 48 hours of treatment start and those treated with other anti-CRAB therapies during the same period. A special subgroup will undergo therapeutic drug monitoring (TDM) where blood samples are collected to measure drug levels, helping to understand the relationship between drug exposure and patient outcomes. Advanced statistical methods will adjust for differences between groups and analyze time-related factors. Participants will have their health monitored through outcome data such as 28-day mortality, clinical failure, microbiological eradication, length of ICU stay, and time to clinical improvement. The study collects clinical and microbiological data, including plasma drug concentrations in the TDM subgroup. Researchers will also track adverse events and perform subgroup analyses based on infection status. The total study duration runs until November 2027, with data collected during routine hospital care.

Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study