BLING III
Research type
Research Study
Full title
A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients.
IRAS ID
238151
Contact name
Stephen Brett
Contact email
Sponsor organisation
The George Institute for Global Health
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2017-004637-85, EudatCT number
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Sepsis is the most common cause of death in critically ill patients, with a quarter of those developing severe sepsis during their hospitalisation. Even though the outcomes of patients with severe sepsis have improved, the number of patients with sepsis has increased. Currently there is no effective treatment for severe sepsis other than prompt administration of fluids, antibiotics and supportive care. These hospital acquired infections are recognised as an increasing public health problem causing more than a million deaths worldwide. It is already well established that administration of beta-lactam antibiotics is beneficial to patients with severe sepsis as these antibiotics treat the most common Gram +ve/-ve bacterial causes of infection. In animal and in vitro models it has been shown that continuous infusion of these antibiotics is superior to intermittent infusion, however human trials have been under-powered to provide significant evidence of this. This trial is aiming to determine whether giving a patient a continuous infusion of a beta lactam compared to an intermittent beta lactam infusion would affect patient outcomes and the vital status of patients at hospital discharge. The George Institute for Global Health is taking a stepwise program of research which to date has included a feasibility pilot randomised controlled trial (BLING I) and a phase IIb trial (BLING II), comparing continuous administration of beta-lactam antibiotics in ICU patients. BLING I had a sample size of 60 patients, BLING II had a sample size of 432 patients and looked at ICU free days at day 28. BLING III will be a definitive global trial to provide necessary evidence on whether there is a survival and economic benefit associated with continuous beta-lactam infusion in sepsis patients.
Summary of Results:
The results are not yet available, this are in process of being published. Once available the ClinicalTrials.gov website will be updated.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0242
Date of REC Opinion
25 May 2018
REC opinion
Favourable Opinion