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. 2023 Nov;24(4):427-434.
doi: 10.1177/17511437231169193. Epub 2023 Apr 25.

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

Paul Dark  1 , Gavin D Perkins  2 , Ronan McMullan  3 , Danny McAuley  3 , Anthony C Gordon  4 , Jonathan Clayton  5 , Dipesh Mistry  2 , Keith Young  2 , Scott Regan  2 , Nicola McGowan  2 , Matt Stevenson  6 , Simon Gates  7 , Gordon L Carlson  8 , Tim Walsh  9 , Nazir I Lone  9 , Paul R Mouncey  10 , Mervyn Singer  11 , Peter Wilson  12 , Tim Felton  13 , Kay Marshall  14 , Anower M Hossain  2 , Ranjit Lall  2
Affiliations

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

Paul Dark et al. J Intensive Care Soc. 2023 Nov.

Abstract

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 for critically ill patients with sepsis. Moreover, if a biomarker-guided protocol is not found to be effective, then it will be important to avoid its use in sepsis and prevent ineffective technology becoming widely adopted in clinical practice.

Keywords: Antibiotic duration; C-reactive protein; biomarkers; procalcitonin; sepsis.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.C.G. reports that outside of this work he has received speaker fees from Orion Corporation Orion Pharma and Amomed Pharma. He has consulted for Ferring Pharmaceuticals, Tenax Therapeutics, Baxter Healthcare, Bristol-Myers Squibb and GSK, and received grant support from Orion Corporation Orion Pharma, Tenax Therapeutics and HCA International with funds paid to his institution. Authors otherwise declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Trial biomarker-guided antibiotic discontinuation protocol.
Figure 2.
Figure 2.
Trial flow diagram.
See this image and copyright information in PMC

References

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