biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial

作者：Paul M Dark, Gavin D. Perkins, Ronan McMullan, Danny McAuley, Anthony C. Gordon, Jonathan B. Clayton, Dipesh Mistry, Keith A. Young, Scott E. Regan, Nicola McGowan, Matt Stevenson, Simon Gates, Gordon L Carlson, Timothy Simon Walsh, Nazir Lone, Paul R. Mouncey, Mervyn Singer, Peter John Wilson, Tim Felton, Kay M. Marshall, Anower M. Hossain, Ranjit Lall · 发表于：Journal of the Intensive Care Society · 年份：2023 · DOI：10.1177/17511437231169193 · 被引用次数：14 · 研究领域：Sepsis Diagnosis and Treatment、Neonatal and Maternal Infections、Hemodynamic Monitoring and Therapy

Aim: To describe the protocol for a multi-centre randomised controlled trial to determine whether treatment protocols monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic therapy in hospitalised adult patients with sepsis. Design: Multicentre three-arm randomised controlled trial. Setting: UK NHS hospitals. Target population: Hospitalised critically ill adults who have been commenced on intravenous antibiotics for sepsis. Health technology: Three protocols for guiding antibiotic discontinuation will be compared: (a) standard care; (b) standard care + daily CRP monitoring; (c) standard care + daily PCT monitoring. Standard care will be based on routine sepsis management and antibiotic stewardship. Measurement of outcomes and costs. Outcomes will be assessed to 28 days. The primary outcomes are total duration of antibiotics and safety outcome of all-cause mortality. Secondary outcomes include: escalation of care/re-admission; infection re-lapse/recurrence; antibiotic dose; length and level of critical care stay and length of hospital stay. Ninety-day all-cause mortality rates will also be collected. An assessment of cost effectiveness will be performed. Conclusion: In the setting of routine NHS care, if this trial finds that a treatment protocol based on monitoring CRP or PCT safely allows a reduction in duration of antibiotic therapy, and is cost effective, then this has the potential to change clinical practice fo...