KCE-17005: Eine randomisierte, kontrollierte Phase-III-Studie zum Vergleich kontinuierlicher oder intermittierender Gabe von Beta-Laktam bei septischen Patienten im kritischen Zustand - BLING III

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

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

 

Dokumente
Protocol: https://www.ncbi.nlm.nih.gov/pubmed/30857514  
Report

 

Publication

 

Referenzen

Clinicaltrials.gov: NCT03212990

Webpage: 

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017