Department of Paediatrics, University of Cambridge, Cambridge, UK
Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.
Lower respiratory tract infection (LRTI) is the most commonly treated infection in critically ill children. Pathogens are infrequently identified on routine respiratory culture, and this is a time-consuming process. A syndromic approach to rapid molecular testing that includes a wide range of bacterial and fungal targets has the potential to aid clinical decision making and reduce unnecessary broad spectrum antimicrobial prescribing. Here, we describe a single-centre prospective cohort study investigating the use of a 52-pathogen TaqMan array card (TAC) for LRTI in the paediatric intensive care unit (PICU).
Critically ill children with suspected LRTI will be enrolled to this 100 patient single-centre prospective observational study in a PICU in the East of England. Samples will be obtained via routine non-bronchoscopic bronchoalveolar lavage which will be sent for standard microbiology culture in addition to TAC. A blood draw will be obtained via any existing vascular access device. The primary outcomes of the study will be (1) concordance of TAC result with routine culture and 16S rRNA gene sequencing and (2) time of diagnostic result from TAC versus routine culture. Secondary outcomes will include impact of the test on total antimicrobial prescriptions, a description of the inflammatory profile of the lung and blood in response to pneumonia and a description of the clinical experience of medical and nursing staff using TAC.
This study has been approved by the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee (REC reference 20/YH/0089). Informed consent will be obtained from all participants. Results will be published in peer-reviewed publications and international conferences.
NCT04233268.
下呼吸道感染（LRTI）是危重症患儿最常治疗的感染。在常规呼吸道培养中很少能确定病原体，这是一个耗时的过程。一种针对快速分子检测的综合征方法，包括广泛的细菌和真菌靶点，有可能帮助临床决策并减少不必要的广谱抗菌药物处方。在这里，我们描述了一项单中心前瞻性队列研究，该研究调查了在儿科重症监护病房（PICU）使用 52 种病原体 TaqMan 阵列卡（TAC）进行 LRTI 的情况。
将对疑似 LRTI 的危重症患儿进行这项 100 例患者的单中心前瞻性观察性研究，研究地点在英格兰东部的 PICU。将通过常规非支气管镜支气管肺泡灌洗获取样本，除 TAC 外，还将进行标准微生物培养。将通过任何现有的血管通路装置采集血液样本。该研究的主要结局将是：（1）TAC 结果与常规培养和 16S rRNA 基因测序的一致性；（2）TAC 与常规培养相比获得诊断结果的时间。次要结局将包括该检测对总抗菌药物处方的影响、肺部和血液对肺炎的炎症特征描述以及医护人员使用 TAC 的临床经验描述。
这项研究已获得约克郡和亨伯-布拉德福德利兹研究伦理委员会（REC 参考号 20/YH/0089）的批准。将从所有参与者那里获得知情同意。研究结果将发表在同行评议的出版物和国际会议上。
NCT04233268。
