Study Comparing Continuous Versus Intermittent Beta-Lactam Antibiotic Infusion and Combination Therapy in Adult ICU Patients With Sepsis

What this Trial Is About

This research focuses on adults hospitalized in the ICU with hospital-acquired sepsis caused by multidrug-resistant Gram-negative bacteria. It aims to compare different methods of giving beta-lactam antibiotics and the use of combination versus single antibiotic therapy. The study uses a 2x2 factorial design to evaluate these approaches for their impact on patient outcomes. Participants are randomly assigned to one of four groups that combine two antibiotic infusion strategies and two aminoglycoside dosing durations. The groups include continuous infusion of beta-lactam antibiotics with either a 5-day aminoglycoside infusion or a single dose, and intermittent beta-lactam infusion with the same aminoglycoside options. Treatment is administered according to the assigned group during the ICU stay. Throughout the study, researchers monitor patients for 30 days to assess mortality rates and kidney-related adverse events. Participants undergo bacteriological sampling before treatment and are followed with several clinical and microbiological evaluations, including infection status and organ function. The study tracks outcomes such as survival, kidney events, infection resolution, and length of ICU and hospital stay, with follow-up extending up to 180 days after inclusion.

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis