Waterfield Thomas, Lyttle Mark D, Fairley Derek, Mckenna James, Woolfall Kerry, Lynn Fiona, Maney Julie-Ann, Roland Damian, Weir Aoife, Shields Michael D
Centre for Experimental Medicine, Wellcome Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK.
Belfast Health and Social Care Trust, Belfast, Northern Ireland.
BMC Pediatr. 2018 Jul 30;18(1):246. doi: 10.1186/s12887-018-1220-x.
Children commonly present to Emergency Departments (ED) with a non-blanching rash in the context of a feverish illness. While most have a self-limiting viral illness, this combination of features potentially represents invasive serious bacterial infection, including meningococcal septicaemia. A paucity of definitive diagnostic testing creates diagnostic uncertainty for clinicians; a safe approach mandates children without invasive disease are often admitted and treated with broad-spectrum antibiotics. Conversely, a cohort of children still experience significant mortality and morbidity due to late diagnosis. Current management is based on evidence which predates (i) the introduction of meningococcal B and C vaccines and (ii) availability of point of care testing (POCT) for procalcitonin (PCT) and Neisseria meningitidis DNA.
This PiC study is a prospective diagnostic accuracy study evaluating (i) rapid POCT for PCT and N. meningitidis DNA and (ii) performance of existing clinical practice guidelines (CPG) for feverish children with non-blanching rash. All children presenting to the ED with a history of fever and non-blanching rash are eligible. Children are managed as normal, with detailed prospective collection of data pertinent to CPGs, and a throat swab and blood used for rapid POCT. The study is running over 2 years and aims to recruit 300 children.
Report on the diagnostic accuracy of POCT for (i) N. meningitidis DNA and (ii) PCT in the diagnosis of early MD Report on the diagnostic accuracy of POCT for PCT in the diagnosis of Invasive bacterial infection Secondary objectives: Evaluate the performance accuracy of existing CPGs Evaluate cost-effectiveness of available diagnostic testing strategies Explore views of (i) families and (ii) clinicians on research without prior consent using qualitative methodology Report on the aetiology of NBRs in children with a feverish illness DISCUSSION: The PiC study will provide important information for policy makers regarding the value of POCT and on the utility and cost of emerging diagnostic strategies. The study will also identify which elements of existing CPGs may merit inclusion in any future study to derive clinical decision rules for this population.
NCT03378258 . Retrospectively registered on December 19, 2017.
儿童在发热性疾病期间常因出现非压之褪色皮疹而前往急诊科就诊。虽然大多数患儿患的是自限性病毒性疾病，但这种症状组合可能意味着侵袭性严重细菌感染，包括脑膜炎球菌败血症。由于缺乏确定性诊断检测方法，临床医生面临诊断不确定性；一种安全的方法是常常收治无侵袭性疾病的儿童并用广谱抗生素进行治疗。相反，仍有一部分儿童因诊断延迟而出现显著的死亡率和发病率。目前的管理是基于在（i）引入B型和C型脑膜炎球菌疫苗之前以及（ii）降钙素原（PCT）和脑膜炎奈瑟菌DNA即时检测（POCT）可用之前的证据。
这项PiC研究是一项前瞻性诊断准确性研究，评估（i）PCT和脑膜炎奈瑟菌DNA的快速POCT以及（ii）针对发热且有非压之褪色皮疹儿童的现有临床实践指南（CPG）的性能。所有因发热和非压之褪色皮疹病史前往急诊科就诊的儿童均符合条件。儿童按常规进行管理，前瞻性详细收集与CPG相关的数据，并采集咽拭子和血液用于快速POCT。该研究为期2年，旨在招募300名儿童。
报告POCT对（i）脑膜炎奈瑟菌DNA和（ii）PCT在早期侵袭性疾病诊断中的诊断准确性 报告POCT对PCT在侵袭性细菌感染诊断中的诊断准确性 次要目标：评估现有CPG的性能准确性 评估可用诊断检测策略的成本效益 使用定性方法探讨（i）家庭和（ii）临床医生对未经事先同意的研究的看法 报告发热性疾病患儿非压之褪色皮疹的病因 讨论：PiC研究将为政策制定者提供有关POCT价值以及新出现诊断策略的效用和成本的重要信息。该研究还将确定现有CPG的哪些要素可能值得纳入未来任何研究，以得出针对该人群的临床决策规则。
NCT03378258。于2017年12月19日进行回顾性注册。
