Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis (NCT06766461) | Clinical Trial Compass
RecruitingPhase 4
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
Netherlands980 participantsStarted 2025-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥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 Criteria:
* 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