Study on Initial High-Dose Beta-Lactam Antibiotics to Improve Outcomes in Critically Ill Adults with Sepsis

What this Trial Is About

Researchers are studying whether giving critically ill adult patients with sepsis a higher initial dose of beta-lactam antibiotics can reduce deaths compared to standard dosing. This open-label, randomized controlled trial focuses on patients admitted to intensive care units who meet sepsis and septic shock criteria. The main goal is to see if this approach lowers death rates within 28 days after enrollment. Participants are randomly assigned to one of two groups. The intervention group receives a double dose of beta-lactam antibiotics for the first 48 hours after joining the trial, while the control group receives the usual standard dose as per local protocols. Treatment is given through intravenous antibiotic therapy, including continuous infusion when applicable. During the study, researchers will monitor several outcomes, including mortality at 28, 90, and 365 days, lengths of stay in the ICU and hospital, time to shock reversal, microbiological eradication, clinical cure, and antibiotic levels in the blood. They will also assess changes in organ failure scores, lactate levels, quality of life, medical resource use, productivity, and adverse events up to 12 months after admission. Follow-up questionnaires will be completed at 3 and 12 months to gather additional data.

Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis