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

Last updated: January 8, 2025
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Double dosing of beta-lactam antibiotic

Clinical Study ID

NCT06766461
2024-512950-13
U1111-1308-9223
2024-512950-13-00
10140022310046
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years of age

  • Receiving intravenous antibiotic therapy of the target drugs (including continuousinfusion of beta-lactam antibiotics)

  • Primary infection

  • Admitted to the ICU

  • Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shockrequiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg orgreater, and a serum lac tate level greater than 2.0 mmol/L following "adequatefluid resuscitation".

Exclusion

Exclusion Criteria:

  • Patient or legal representative not available to give informed consent within 72hours after admittance

  • Pregnancy

  • Admittance for burn wounds

  • Patients receiving target antibiotics only as prophylaxis within the context ofSelective 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 suspectedinfection

Study Design

Total Participants: 980
Treatment Group(s): 1
Primary Treatment: Double dosing of beta-lactam antibiotic
Phase: 4
Study Start date:
January 03, 2025
Estimated Completion Date:
December 01, 2027

Study Description

Objective

To determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients.

Main trial endpoints

The main trial endpoint is all cause 28-day mortality.

Secondary trial endpoints

Secondary trial endpoints include: Hospital length of stay, ICU length of stay, microbiological eradication, time to shock reversal, clinical cure, Δ Lactate, Δ PCT, Δ SOFA, 90- day mortality, 365-day mortality, pharmacodynamic target, post study calculation of the costs in both study, groups, EQ5D questionnaire 3 and 12 months after Admission, iMTA productivity questionnaire 3 and 12 months after admission, iMTA medical consumption questionnaire 3 and 12 months after admission and the number of adverse events.

Trial design

This is an open label, randomized controlled trial.

Trial population

The trial population will consist of adult patients admitted to the intensive care department with sepsis who will be treated according to protocol with beta-lactam antibiotics.

Interventions

During the trial participants in the intervention group will receive a double dose of antibiotics for the first 48 hours in comparison to the standard dose in the control group.

Connect with a study center

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

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