A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients (KCE-17005)

Summary (French or Dutch)

There is global uncertainty as to the best way to administer beta-lactam antibiotics for critically ill patients with sepsis.

The Beta-Lactam Infusion Group (BLING) III study, is a study to find out whether continuous infusion of beta-lactam antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health advantages to patients or if there is no difference.

The investigators will be looking to see whether patients receiving beta-lactams via one administration method or the other have a better chance of recovering from their illness. They will also be looking at long term outcomes such as quality-of-life and healthcare resource use.

Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body.

Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in patients with sepsis and septic shock.

Currently, beta-lactam antibiotics are most commonly given to patients by intermittent infusions, which means, given at regular intervals throughout 24 hours. New research suggests that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic concentrations in the blood remain more consistent and may be more effective at killing bacteria.

However, the benefit to the patient by giving beta-lactams via continuous infusion has not been tested in a high-quality, large clinical trial.

This study is part of an international multi-site trial with more than 7000 patients involved to find an answer to this relevant clinical question.

 

Trial Description
Title

A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients - KCE-17005

Participants (P)

Critically ill patients with confirmed or suspected infection hospitalised at ICU

Intervention (I)

Continuous infusion of β-lactam antibiotic

Control (C)

Intermittent infusion of β-lactam antibiotic

Outcome (O)

90-day all-cause mortality

Trial Design

Prospective, multicentre, open, phase III, randomised clinical trial

Sample Size

Total sample size of 7,000 (3,500 in each group), 700 (up to 875) patients in Belgium.

Other participating countries: Australia, New Zealand, UK, Sweden, Spain, Portugal

Trial duration

48 months

Budget

€ M1.26 (incl VAT) – general project management and data management by the sponsor team in Australia. Local project management and monitoring by the Belgian Coordinating Centre

Status

Open to recruitment

 

Trial team

Sponsor

International sponsor: The George Institute for Global Health, Australia

Belgian Coordinating Centre: UZ GENT

Chief Investigator

Prof Dr Jan De Waele, Dept. of Critical Care Medicine - Surgical Intensive Care Unit

Ghent University Hospital, C. Heymanslaan 10, 9000 Gent

Participating Investigators

7 intensive care units in general hospitals and teaching hospitals in the North and South of Belgium
Documents
Protocol: http://www.ncbi.nlm.nih.gov/pubmed/30857514  
Report

 

Publication

 

References

Clinicaltrials.gov: NCT03212990

Webpage: 

Funding scheme

Investigator-led workstream 2017