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)

Maasstad Ziekenhuis

Rotterdam, Netherlands

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NCT06766461


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