NCT06766461

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 980 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.

Detailed description

Objective To determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients. Main trial endpoints The main trial endpoint is all cause 28-day mortality. Secondary trial endpoints Secondary trial endpoints include: Hospital length of stay, ICU length of stay, microbiological eradication, time to shock reversal, clinical cure, Δ Lactate, Δ PCT, Δ SOFA, 90- day mortality, 365-day mortality, pharmacodynamic target, post study calculation of the costs in both study, groups, EQ5D questionnaire 3 and 12 months after Admission, iMTA productivity questionnaire 3 and 12 months after admission, iMTA medical consumption questionnaire 3 and 12 months after admission and the number of adverse events. Trial design This is an open label, randomized controlled trial. Trial population The trial population will consist of adult patients admitted to the intensive care department with sepsis who will be treated according to protocol with beta-lactam antibiotics. Interventions During the trial participants in the intervention group will receive a double dose of antibiotics for the first 48 hours in comparison to the standard dose in the control group.

Conditions

• Sepsis - to Reduce Mortality in the Intensive Care Unit
• Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	Double dosing of beta-lactam antibiotic	This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.

Timeline

• Start date: 2025-01-03
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: Netherlands