Actively Recruiting
Led by Erasmus Medical Center · Updated on 2025-01-09
980
Participants Needed
1
Research Sites
52 weeks
Total Duration
E
Erasmus Medical Center
Lead Sponsor
M
Maasstad Hospital
Collaborating Sponsor
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.
CONDITIONS
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - First 48 hours after enrollment
Participants receive beta-lactam antibiotics; those in the intervention group receive double dosing for the first 48 hours, while the control group receives the standard dose.
Daily visits for 2 days
Duration - Up to 12 months after enrollment
Participants are monitored for clinical outcomes including mortality, length of stay, clinical cure, and quality of life for up to 12 months.
Visits at 3, 12 months and additional assessments during hospital stay
Total: 1 location
1
Maasstad Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
B
Birgit C.P. Koch, PharmD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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M M B Horstink, D R Geel, C A den Uil...
https://pubmed.ncbi.nlm.nih.gov/40119275