Today on World Sepsis Day (13th September 2020), as both members of the public and health professionals alike, we can all learn more about how to spot signs of sepsis. Whilst there are many conditions where a watchful waiting approach to management can be taken, with sepsis speed really is of the essence. This means that it is important to be aware of and familiar with the classic signs of sepsis<\/a>. However, actual diagnosis of sepsis is hard, so this heightened awareness inevitably leads to more and more patients receiving antibiotics \u2018just in case\u2019. So we are left with a balancing act between our desire to reduce the use of unnecessary antibiotics and the need to reduce deaths from this terrible condition.<\/p>\n\n\n\n Current research is focussed on helping health professionals to use antibiotics judiciously \u2013 i.e. targeted to those who need them. This is the premise behind both the BATCH<\/a> and the PRONTO<\/a> trials run thorough the Centre for Trials Research<\/a>. The BATCH trial is focused on children in hospital who have suspected infections who need intravenous antibiotics. It uses a protein biomarker (procalcitonin) found in the blood to see if this can shorten the time that they are on these intravenous antibiotics, by more accurately assessing recovery. The PRONTO trial is looking at adults in the emergency department with suspected sepsis to see if this blood marker can be used to decide whether to start antibiotic treatment. PRONTO also uses procalcitonin as the biomarker, but features a bench top machine which can provide an answer within 20 minutes. These studies are funded by the NIHR to provide vital evidence to guide future practice.<\/p>\n\n\n\n Both of these studies face a challenge in design. We want to reduce antibiotic use, but these are patients who are ill and there would be concerns that we might not give antibiotics to those who really need them. Therefore we have designed them to consider two outcomes simultaneously, which is unusual in clinical trials. Both studies are designed to look at reducing antibiotics, but without having a bad impact clinically on the patient. This second or \u2018non-inferiority\u2019 outcome to show that things do not get worse for patients when we use the blood marker to drive treatment is vital to the study, but also challenging. In order to design these studies we need to decide on a \u2018non-inferiority margin\u2019 which is what is considered a negligible difference. <\/p>\n\n\n\n For BATCH this is a safety measure made up of a number of different events including needing to restart the intravenous antibiotics, but also admission to intensive care, whilst for PRONTO this safety measure is death. We have two very active patient groups who have been involved in helping us design these studies and considering the acceptability of the outcomes. We have also planned the studies to allow us to stop them early if there is a concern regarding patient safety, or if there is a large benefit.<\/p>\n\n\n\n It is vitally important that as researchers we design and deliver studies which help health professionals and patients with diagnosing and managing sepsis. These studies may need us to think differently about how we design our studies, however working in partnership with patients makes this possible.<\/p>\n\n\n\n Reference: https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(18)30289-5\/fulltext<\/a><\/p>\n\n\n\n \u2013 Dr Emma Thomas-Jones<\/a> and Professor Kerry Hood<\/a><\/p>\n\n\n\n #WorldSepsisDay #StopSepsis #SaveLives<\/p>\n","protected":false},"excerpt":{"rendered":"Sepsis and Antimicrobial Resistance (AMR)? Today on World Sepsis Day (13th September 2020), as both members of the public and health professionals alike, we can all learn more about how […]","protected":false},"author":1544,"featured_media":1923,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7],"tags":[100,88],"class_list":["post-1922","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","tag-antimicrobial-resistance","tag-sepsis"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7dIou-v0","jetpack-related-posts":[{"id":1695,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/world-sepsis-day-2019\/","url_meta":{"origin":1922,"position":0},"title":"World Sepsis Day 2019","author":"Kerry Hood","date":"September 13, 2019","format":false,"excerpt":"How can we reduce deaths from sepsis without contributing to the problem of antimicrobial resistance (AMR)? Today on World Sepsis Day (13th September 2019), as both members of the public and health professionals alike, we can all learn more about how to spot signs of sepsis.\u00a0 Whilst there are many\u2026","rel":"","context":"In "Infections"","block_context":{"text":"Infections","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/infections\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/World-Sepsis-Day.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2144,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/one-year-of-the-pronto-trial-challenges-observed-and-overcome-during-a-global-pandemic\/","url_meta":{"origin":1922,"position":1},"title":"One Year Of The PRONTO Trial: Challenges Observed And Overcome During A Global Pandemic","author":"Joanne Euden","date":"November 18, 2021","format":false,"excerpt":"What Is Sepsis? Sepsis, blood poisoning, septicaemia\u2026whatever word you are familiar with, it remains one of the most common complications of infection seen in hospital Emergency Departments (ED)s across the UK and is characterised by an unregulated host response to bacterial infection. Optimal treatment for sepsis includes prompt antibiotics into\u2026","rel":"","context":"In "Antibiotics"","block_context":{"text":"Antibiotics","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/antibiotics\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/img.youtube.com\/vi\/H3x-rNVlwJI\/0.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2961,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/my-pronto-journey-world-sepsis-day-2024\/","url_meta":{"origin":1922,"position":2},"title":"My PRONTO Journey – World Sepsis Day 2024","author":"Joanne Euden","date":"September 13, 2024","format":false,"excerpt":"-Blog by Julie Carman As World Sepsis day comes round again, I invite you to join me as I share my thoughts and observations as the Patient and Public Involvement (PPI) representative on working with the PRONTO trial research team. The PRONTO Trial PRONTO (PROcalcitonin and NEWS2 evaluation for Timely\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"Photo of the PRONTO study team.","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/09\/PRONTO-team-cropped.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2651,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/navigating-the-seas-of-trial-management-my-journey-with-the-pronto-trial\/","url_meta":{"origin":1922,"position":3},"title":"Navigating the Seas of Trial Management: My Journey with the PRONTO Trial","author":"Waku Maboshe","date":"September 13, 2023","format":false,"excerpt":"Introduction As we mark World Sepsis Day, I find myself reflecting on a journey that has been both challenging and deeply rewarding - my role as a new trial manager for the PRONTO trial. PRONTO, the largest clinical trial for sepsis in the UK, has been a monumental undertaking, and\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/Waku-Maboshe.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/Waku-Maboshe.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/Waku-Maboshe.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/Waku-Maboshe.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/Waku-Maboshe.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2714,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/world-amr-awareness-week-2023-the-centre-for-trials-research-i3-division\/","url_meta":{"origin":1922,"position":4},"title":"World AMR Awareness Week 2023: The Centre for Trials\u00a0Research\u00a0I3 Division","author":"Joanne Euden","date":"November 17, 2023","format":false,"excerpt":"World AMR Awareness Week: The Centre for Trials\u00a0Research\u00a0I3 Division highlight the research they do to improve diagnosis of infections to guide appropriate antibiotic use\u00a0and\u00a0reduce the spread of antimicrobial resistance. Background Antimicrobial Resistance (AMR) is an urgent global public health threat, whereby increasing numbers of bacteria are becoming resistant to commonly\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/11\/Antimicrobial-resistance.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/11\/Antimicrobial-resistance.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/11\/Antimicrobial-resistance.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/11\/Antimicrobial-resistance.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2652,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/how-the-patient-voice-adds-to-community-healthcare-and-health-research\/","url_meta":{"origin":1922,"position":5},"title":"How The Patient Voice Adds To Community, Healthcare And Health Research","author":"Joanne Euden","date":"September 13, 2023","format":false,"excerpt":"Using lived experience to improve health outcomes In 2008 I was knocked off my bike in a road traffic accident. Initially, I recovered well after a few weeks in hospital. However, a couple of months later, and back at home, my health began to deteriorate. I had developed sepsis, probably\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/09\/20221201_105151-scaled.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"meta_box":[],"jetpack_featured_media_url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2020\/09\/PRONTO-team.jpg","_links":{"self":[{"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/posts\/1922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/users\/1544"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/comments?post=1922"}],"version-history":[{"count":1,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/posts\/1922\/revisions"}],"predecessor-version":[{"id":1924,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/posts\/1922\/revisions\/1924"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/media\/1923"}],"wp:attachment":[{"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/media?parent=1922"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/categories?post=1922"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-json\/wp\/v2\/tags?post=1922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}BATCH and PRONTO<\/h2>\n\n\n\n
Design Challenges<\/h2>\n\n\n\n