Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Double dosing of beta-lactam antibiotic
DrugThis arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.
Treatment groups
980 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
28-day mortality
Time frame
From enrollment to 28 daysSecondary outcomes
1
90-day mortality
Time frame
From enrollment to 90 days2
365-day mortality
Time frame
From enrollment to the 365 days3
ICU lengt of stay
Time frame
From enrollment to the end of the study period at 12 months4
Hospital lengt of stay
Time frame
From enrollment to the end of the study period at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Maasstad Hospital
Collaborator
Albert Schweitzer Hospital
Collaborator
Source ClinicalTrials.gov