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

Recruiting now · Phase 4

Conditions studied: Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis, Septic Shock

In brief

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.

Key facts

Study ID

NCT06766461

Run by

Erasmus Medical Center

People needed

980

Starts

2025-01-03

Expected to finish

2027-12-01

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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".

You may not qualify if…

• 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

Where it is running

• Maasstad Ziekenhuis — Rotterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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