Lipman Jeffrey, Brett Stephen J, De Waele Jan J, Cotta Menino O, Davis Joshua S, Finfer Simon, Glass Parisa, Knowles Serena, McGuinness Shay, Myburgh John, Paterson David L, Peake Sandra, Rajbhandari Dorrilyn, Rhodes Andrew, Roberts Jason A, Shirwadkar Charudatt, Starr Therese, Taylor Colman, Billot Laurent, Dulhunty Joel M
Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
Imperial College Healthcare NHS Trust, London, United Kingdom.
Crit Care Resusc. 2019 Mar;21(1):63-68.
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).
β-内酰胺类抗生素呈现出时间依赖性作用机制，有证据表明，与标准间歇性输注相比，通过持续输注方式使用这些药物时疗效更佳。然而，尚无Ⅲ期随机对照试验（RCT）证据支持在重症脓毒症患者中哪种给药方式优于另一种。
β-内酰胺输注组（BLING）Ⅲ研究是一项前瞻性、多中心、开放性Ⅲ期RCT，旨在比较重症脓毒症患者中β-内酰胺类抗生素持续输注与标准间歇性输注的效果。该研究将于2018年至2021年在澳大利亚、新西兰、英国、比利时及其他选定国家的约70个重症监护病房（ICU）中开展。
BLINGⅢ将招募7000例接受两种β-内酰胺类抗生素（哌拉西林-他唑巴坦或美罗培南）之一治疗的重症脓毒症患者，通过持续或间歇性输注接受β-内酰胺类抗生素治疗。
主要结局为随机分组后90天内的全因死亡率。次要结局为随机分组后第14天的临床治愈情况、随机分组后长达14天内多重耐药菌或艰难梭菌腹泻的新感染、定植或感染情况、全因ICU死亡率和全因医院死亡率。三级结局为随机分组后长达90天内的ICU住院时间、医院住院时间、机械通气时间和肾脏替代治疗时间。
BLINGⅢ研究将比较7000例重症脓毒症患者中β-内酰胺类抗生素持续输注与间歇性输注对90天死亡率的影响。
ClinicalTrials.gov注册库（NCT03213990）。
