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biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis) : a protocol for a multicentre randomised controlled trial
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(2023) biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis) : a protocol for a multicentre randomised controlled trial. Journal of the Intensive Care Society . doi:10.1177/17511437231169193 ISSN 1751-1437. (In Press)
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WRAP-biomArker-guided-Duration-Antibiotic-treatment-hospitalised-Patients-suspecTed-Sepsis-(ADAPT-Sepsis)-2023.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (338Kb) | Preview |
Official URL: https://doi.org/10.1177/17511437231169193
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.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| SWORD Depositor: | Library Publications Router | ||||||
| Library of Congress Subject Headings (LCSH): | Antibiotics, Septicemia, Septicemia -- Treatment, Calcitonin, Critical care medicine, Drug resistance in microorganisms, Clinical trials | ||||||
| Journal or Publication Title: | Journal of the Intensive Care Society | ||||||
| Publisher: | Sage Publications Ltd. | ||||||
| ISSN: | 1751-1437 | ||||||
| Official Date: | 25 April 2023 | ||||||
| Dates: |
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| DOI: | 10.1177/17511437231169193 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | In Press | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 26 July 2023 | ||||||
| Date of first compliant Open Access: | 26 July 2023 | ||||||
| RIOXX Funder/Project Grant: |
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