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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-03

Study Completion Date

2027-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

NCT03628300

Neurotoxicity Sepsis Beta Lactams +3 more

COMPLETED

Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

NCT01139489

Sepsis Severe Sepsis Septic Shock

COMPLETED NA

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

NCT05681442

Sepsis

RECRUITING PHASE4

Early Optimization of Ceftazidime Regimen in Critical Care

NCT07085624

Infection in ICU Sepsis Septic Shock +1 more

NOT_YET_RECRUITING NA

Pharmacokinetic of Ceftriaxone in Septic ICU Patients

NCT00449800

Sepsis Severe Sepsis Septic Shock

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

This arm will receive standard of care according to local protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

This arm will be treated with double dosages of beta-lactam antibiotics the first 48 hours after inclusion.

Group Type EXPERIMENTAL

Double dosing of beta-lactam antibiotic

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Double dosing of beta-lactam antibiotic

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No