A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis: BLING III.
Anti-Bacterial Agents
/ administration & dosage
Australia
Critical Illness
/ therapy
Drug Administration Schedule
Humans
Infusions, Intravenous
Meropenem
/ administration & dosage
New Zealand
Piperacillin, Tazobactam Drug Combination
/ administration & dosage
Prospective Studies
Sepsis
/ drug therapy
Treatment Outcome
United Kingdom
beta-Lactams
/ administration & dosage
Journal
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
ISSN: 1441-2772
Titre abrégé: Crit Care Resusc
Pays: Netherlands
ID NLM: 100888170
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
entrez:
13
3
2019
pubmed:
13
3
2019
medline:
29
5
2019
Statut:
ppublish
Résumé
β-Lactam antibiotics display a time-dependent mechanism of action, with evidence suggesting improved outcomes when administering these drugs via continuous infusion compared with standard intermittent infusion. However, there is no phase 3 randomised controlled trial (RCT) evidence to support one method of administration over another in critically ill patients with sepsis. The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 RCT to compare continuous infusion with standard intermittent infusion of β-lactam antibiotics in critically ill patients with sepsis. The study will be conducted in about 70 intensive care units (ICUs) in Australia, New Zealand, the United Kingdom, Belgium and selected other countries, from 2018 to 2021. BLING III will recruit 7000 critically ill patients with sepsis being treated with one of two β-lactam antibiotics (piperacillin-tazobactam or meropenem) to receive the β-lactam antibiotic by either continuous or intermittent infusion. The primary outcome is allcause mortality within 90 days after randomisation. Secondary outcomes are clinical cure at Day 14 after randomisation, new acquisition, colonisation or infection with a multiresistant organism or Clostridium difficile diarrhoea up to 14 days after randomisation, all-cause ICU mortality and all-cause hospital mortality. Tertiary outcomes are ICU length of stay, hospital length of stay and duration of mechanical ventilation and duration of renal replacement therapy up to 90 days after randomisation. The BLING III study will compare the effect on 90-day mortality of β-lactam antibiotics administered via continuous versus intermittent infusion in 7000 critically ill patients with sepsis. ClinicalTrials.gov Registry (NCT03213990).
Sections du résumé
BACKGROUND AND RATIONALE
OBJECTIVE
β-Lactam antibiotics display a time-dependent mechanism of action, with evidence suggesting improved outcomes when administering these drugs via continuous infusion compared with standard intermittent infusion. However, there is no phase 3 randomised controlled trial (RCT) evidence to support one method of administration over another in critically ill patients with sepsis.
DESIGN AND SETTING
METHODS
The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 RCT to compare continuous infusion with standard intermittent infusion of β-lactam antibiotics in critically ill patients with sepsis. The study will be conducted in about 70 intensive care units (ICUs) in Australia, New Zealand, the United Kingdom, Belgium and selected other countries, from 2018 to 2021.
PARTICIPANTS AND INTERVENTIONS
METHODS
BLING III will recruit 7000 critically ill patients with sepsis being treated with one of two β-lactam antibiotics (piperacillin-tazobactam or meropenem) to receive the β-lactam antibiotic by either continuous or intermittent infusion.
MAIN OUTCOME MEASURES
METHODS
The primary outcome is allcause mortality within 90 days after randomisation. Secondary outcomes are clinical cure at Day 14 after randomisation, new acquisition, colonisation or infection with a multiresistant organism or Clostridium difficile diarrhoea up to 14 days after randomisation, all-cause ICU mortality and all-cause hospital mortality. Tertiary outcomes are ICU length of stay, hospital length of stay and duration of mechanical ventilation and duration of renal replacement therapy up to 90 days after randomisation.
RESULTS AND CONCLUSIONS
CONCLUSIONS
The BLING III study will compare the effect on 90-day mortality of β-lactam antibiotics administered via continuous versus intermittent infusion in 7000 critically ill patients with sepsis.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Registry (NCT03213990).
Substances chimiques
Anti-Bacterial Agents
0
beta-Lactams
0
Piperacillin, Tazobactam Drug Combination
157044-21-8
Meropenem
FV9J3JU8B1
Banques de données
ClinicalTrials.gov
['NCT03213990']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM