PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to Carbapenem-resistant Enterobacterales (CRE)

What this Trial Is About

This research investigates adult patients aged 18 years and older who have infections caused by carbapenem-resistant Enterobacterales (CRE), a type of gram-negative bacteria that can be difficult to treat. The study focuses on understanding how the drugs ceftazidime/avibactam (CAZ/AVI) alone or combined with fosfomycin (FOS) work in treating these infections. Researchers aim to assess the effectiveness of these treatments and explore their relationship with patient outcomes, especially in serious infections where treatment exposure may be affected by conditions like kidney disease. Patients in this study have been treated for at least 48 hours with either CAZ/AVI alone or CAZ/AVI combined with FOS for confirmed CRE infections. The study observes how the drugs are administered and measures their concentration in the blood to understand the best ways to achieve effective treatment. This includes evaluating different methods of giving the medications and how these impact patient response. During participation, patients will be monitored from the start of their treatment through 72 hours afterward and followed up to three months. Researchers will assess key outcomes including drug efficacy targets, changes in organ function scores, inflammation markers like C-reactive protein and procalcitonin, infection clearance, relapse or reinfection rates, and overall survival. The study is observational and collects data to better understand treatment responses and outcomes in real-world settings.

PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE