Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care 'test-and-treat' strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol
Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care 'test-and-treat' strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol
复制标题
DOI：
10.1136/bmjopen-2019-031674
复制
发表时间：
2019-12-01
期刊：
影响因子：
2.9
通讯作者：
Clark, Tristan
中科院分区：
文献类型：
--
作者：
Beard, Kate;Brendish, Nathan;Clark, Tristan
由于缺乏常规检测，住院患者的流感感染通常无法诊断。当检测时，由于集中实验室PCR检测的周转时间缓慢，流感的诊断和治疗往往会延迟。较新的分子系统具有与实验室PCR检测相当的准确性，并且可以在1小时内生成结果，使其具有潜在的即时检测（POCT）的可部署性。然而，目前缺乏流感常规POCT对临床结局影响的高质量证据。这个大的务实的多中心随机对照试验的目的是解决这个evidencegap.Methods和分析的FluPOC试验是一个务实的，多中心，随机对照试验评估成人承认一个大型教学医院和地区综合医院急性呼吸道疾病，在流感季节和公共卫生英格兰定义。将在最多三个流感季节招募最多840例患者，并随机（1：1）接受使用FilmArray呼吸道检测试剂盒的POCT或常规临床护理。临床和感染控制小组将被告知真实的时间的结果，并在流感检测临床小组将被鼓励提供神经氨酸酶抑制剂（NAI）治疗按照国家指导方针。那些被分配到标准临床护理的人将采集拭子用于以后的分析，以评估漏诊。结局评估将通过回顾性病例记录分析进行。结果指标包括检测到流感阳性患者并使用NAI进行适当治疗的比例、隔离设施使用情况、抗生素使用情况、住院时间、并发症和死亡率。伦理和传播在开始研究之前，获得了South Central Hampshire A伦理委员会的批准（参考17/SC/0368，于2017年9月7日授予）。本方案产生的结果将发表在同行评审的科学期刊上，并在国家和国际会议上发表。
Background Influenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.Methods and analysis The FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.Ethics and dissemination Prior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences.