Biomarker-Guided Antibiotic Duration for Hospitalized Patients With Suspected Sepsis: The ADAPT-Sepsis Randomized Clinical Trial.

• Tác giả: David Brealey, Gordon Carlson, Jonathan C Clayton, Paul Dark, Timothy W Felton, Belinder K Ghuman, Anthony C Gordon, Thomas P Hellyer, Anower Hossain, Ranjit Lall, Nazir I Lone, Uzma Manazar, Daniel F McAuley, Iain J McCullagh, Ronan McMullan, James J McNamee, Hannah C McNeil, Paul R Mouncey, Micheal J Naisbitt, Robert J Parker, Gavin D Perkins, Ruth L Poole, Gillian Richards, Anthony J Rostron, Mervyn Singer, Matt D Stevenson, Tim S Walsh, Ingeborg D Welters, Tony Whitehouse, Simon Whiteley, Peter Wilson, Keith K Young
• Ngôn ngữ: eng
• Ký hiệu phân loại: 650.142 Resumes, cover letters, job applications
• Thông tin xuất bản: United States : JAMA , 2025
• Bộ sưu tập: NCBI
• ID: 751357

Tóm tắt

 IMPORTANCE: For hospitalized critically ill adults with suspected sepsis, procalcitonin (PCT) and C-reactive protein (CRP) monitoring protocols can guide the duration of antibiotic therapy, but the evidence of the effect and safety of these protocols remains uncertain. OBJECTIVE: To determine whether decisions based on assessment of CRP or PCT safely results in a reduction in the duration of antibiotic therapy. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, intervention-concealed randomized clinical trial, involving 2760 adults (≥18 years), in 41 UK National Health Service (NHS) intensive care units, requiring critical care within 24 hours of initiating intravenous antibiotics for suspected sepsis and likely to continue antibiotics for at least 72 hours. INTERVENTION: From January 1, 2018, to June 5, 2024, 918 patients were assigned to the daily PCT-guided protocol, 924 to the daily CRP-guided protocol, and 918 assigned to standard care. MAIN OUTCOMES AND MEASURES: The primary outcomes were total duration of antibiotics (effectiveness) and all-cause mortality (safety) to 28 days. Secondary outcomes included critical care unit data and hospital stay data. Ninety-day all-cause mortality was also collected. RESULTS: Among the randomized patients (mean age 60.2 [SD, 15.4] years
  60.3% males), there was a significant reduction in antibiotic duration from randomization to 28 days for those in the daily PCT-guided protocol compared with standard care (mean duration, 10.7 [SD, 7.6] days for standard care and 9.8 [SD, 7.2] days for PCT
  mean difference, 0.88 days
  95% CI, 0.19 to 1.58, P = .01). For all-cause mortality up to 28 days, the daily PCT-guided protocol was noninferior to standard care, where the noninferiority margin was set at 5.4% (19.4% [170 of 878] of patients receiving standard care
  20.9% [184 of 879], PCT
  absolute difference, 1.57
  95% CI, -2.18 to 5.32
  P = .02). No difference was found in antibiotic duration for standard care vs daily CRP-guided protocol (mean duration, 10.6 [7.7] days for CRP
  mean difference, 0.09
  95% CI, -0.60 to 0.79
  P = .79). For all-cause mortality, the daily CRP-guided protocol was inconclusive compared with standard care (21.1% [184 of 874] for CRP
  absolute difference, 1.69
  95% CI, -2.07 to 5.45
  P = .03). CONCLUSIONS AND RELEVANCE: Care guided by measurement of PCT reduces antibiotic duration safely compared with standard care, but CRP does not. All-cause mortality for CRP was inconclusive. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN47473244.