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Recruiting NCT06766461

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

Phase IV Interventional Sepsis - to Reduce Mortality in the Intensive Care Unit Sepsis Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Double dosing of beta-lactam antibiotic.
Who it may be relevant to
Registry conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis, Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Drug Double dosing of beta-lactam antibiotic
    This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.

Primary outcome measures

  • 28-day mortality [Time frame: From enrollment to 28 days]
Secondary outcome measures (12)
  • 90-day mortality [Time frame: From enrollment to 90 days]
  • 365-day mortality [Time frame: From enrollment to the 365 days]
  • ICU lengt of stay [Time frame: From enrollment to the end of the study period at 12 months]
  • Hospital lengt of stay [Time frame: From enrollment to the end of the study period at 12 months]
  • Time to shock reversal [Time frame: From enrollment to the end of the study period at 12 months]
  • Microbiological eradication [Time frame: From enrollment to hospital discharge]
  • Clinical cure [Time frame: From enrollment to 14 days]
  • Plasma concentrations of the beta-lactam antibiotics [Time frame: From enrollment to day 3]
  • Delta SOFA [Time frame: From enrollment to day 3]
  • Delta Lactate [Time frame: From enrollment to day 3]
  • Quality of life [Time frame: 3 and 12 months after inclusion]
  • Medical consumption [Time frame: 3 and 12 months after inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Maasstad Ziekenhuis — Rotterdam

Publications

  • Horstink MMB, Geel DR, den Uil CA, Deetman PE, Endeman H, Abdulla A, Bosch TM, Rietdijk WJR, Thielen FW, Haringman JJ, van Vliet P, Rijpstra TA, Bethlehem C, Beishuizen A, Muller AE, Koch BCP; BULLSEYE investigators. Standard versus double dosing of beta-lactam antibiotics in critically ill patients with sepsis: The BULLSEYE study protocol for a multicenter randomized controlled trial. BMC Infect PMID 40119275

Identifiers

NCT: NCT06766461 · 2024-512950-13 · 10140022310046 · 2024-512950-13-00 · U1111-1308-9223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗