RecruitingPhase 4NCT06766461
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
Sponsor
Erasmus Medical Center
Enrollment
980 participants
Start Date
Jan 3, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- ≥18 years of age
- Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)
- Primary infection
- Admitted to the ICU
- Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg or greater, and a serum lac tate level greater than 2.0 mmol/L following "adequate fluid resuscitation".
Exclusion Criteria8
- Patient or legal representative not available to give informed consent within 72 hours after admittance
- Pregnancy
- Admittance for burn wounds
- Patients receiving target antibiotics only as prophylaxis within the context of Selective Diges tive tract Decontamination (SDD)
- Enrolment in another interventional trial
- Patient received the study antibiotic for more than 24 hours before inclusion
- Patient receiving extracorporeal membrane oxygenation (ECMO)
- Patient is already treated with a double dose of antibiotics based on suspected infection
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Interventions
DRUGDouble dosing of beta-lactam antibiotic
This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06766461
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