Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.
PEDEGO (Pediatrics, Dermatology, Gynecology, Obstetrics) Research Unit and Medical Research Centre Oulu, University of Oulu, Oulu, Finland.
JAMA Netw Open. 2022 Jun 1;5(6):e2216162. doi: 10.1001/jamanetworkopen.2022.16162.
Limited data are available on the clinical impact of multiplex polymerase chain reaction (PCR) point-of-care testing for respiratory pathogens in acutely ill children.
To evaluate the effect of multiplex PCR point-of-care testing for respiratory pathogens on antibiotic use in acutely ill children.
DESIGN, SETTING, AND PARTICIPANTS: This unblinded, randomized clinical trial was conducted from May 6, 2019, through March 12, 2020. The participants were followed up until hospitalization or discharge from the emergency department (ED) for primary outcome. The study was conducted at the pediatric ED of Oulu University Hospital, Finland. Eligible study participants were children aged 0 to 17 years with fever and/or any respiratory signs or symptoms. Children with underlying medical conditions were included. The statistical analyses were performed between August 11, 2020, and September 14, 2021.
The participants were randomly assigned in a 2:1 ratio either to undergo multiplex PCR point-of-care testing (18 respiratory viruses and 3 bacteria with results ready within 70 minutes) upon arrival at the ED or to receive routine care.
The primary outcome was the proportion of children receiving antibiotic therapy. The secondary outcomes were the numbers of diagnostic tests and radiographic imaging procedures performed and costs.
A total of 1417 children were assessed for eligibility. After exclusions, 1243 children (692 boys [56%]) were randomly allocated to either the intervention (829 children) or control (414 children) group. The mean (SD) age of the participants was 3.0 (3.6) years in the intervention group (median [IQR], 1.7 [0.4-4.1] years) and 3.0 (3.5) years (median [IQR], 1.9 [0.4-4.1] years) in the control group. Multiplex PCR point-of-care testing for respiratory pathogens did not reduce the overall prescribing of antibiotics in the emergency department (226 children [27.3%] in the intervention group vs 118 children [28.5%] in the control group; risk ratio, 0.96; 95% CI, 0.79-1.16). Targeted antibiotic therapy was started in 12 children (1.4%) tested with point-of-care multiplex PCR and 2 children (0.5%) in the control group (risk ratio, 3.0; 95% CI, 0.76-11.9). The numbers of diagnostic tests did not differ between the groups, nor did the costs.
In this randomized clinical trial, point-of-care testing for respiratory pathogens did not reduce the use of antibiotics at the pediatric ED. Testing for respiratory pathogens appears to have a limited impact on clinical decision-making for acutely ill children.
ClinicalTrials.gov Identifier: NCT03932942.
关于急性病儿童即时检测呼吸道病原体的多重聚合酶链反应（PCR）对临床的影响，相关数据有限。
评估呼吸道病原体多重 PCR 即时检测对急性病儿童抗生素使用的影响。
设计、地点和参与者：这是一项于 2019 年 5 月 6 日至 2020 年 3 月 12 日进行的、未设盲的、随机临床试验。主要结局的随访时间截止到住院或从急诊室（ED）出院。该研究在芬兰奥卢大学医院儿科 ED 进行。合格的研究参与者为年龄在 0 至 17 岁之间、发热和/或任何呼吸道症状或体征的儿童。包括有基础疾病的儿童。统计分析于 2020 年 8 月 11 日至 2021 年 9 月 14 日进行。
参与者随机分为 2:1 比例，一组在 ED 到达时进行即时检测呼吸道病原体的多重 PCR（18 种呼吸道病毒和 3 种细菌，结果在 70 分钟内得出），另一组接受常规护理。
主要结局是接受抗生素治疗的儿童比例。次要结局是诊断性检测和影像学检查的数量和成本。
共有 1417 名儿童接受了入选评估。排除后，1243 名儿童（692 名男孩[56%]）被随机分配到干预组（829 名儿童）或对照组（414 名儿童）。干预组参与者的平均（SD）年龄为 3.0（3.6）岁（中位数[IQR]，1.7 [0.4-4.1] 岁），对照组为 3.0（3.5）岁（中位数[IQR]，1.9 [0.4-4.1] 岁）。即时检测呼吸道病原体的多重 PCR 并不能减少急诊室的抗生素总体处方量（干预组 226 名[27.3%]儿童，对照组 118 名[28.5%]儿童；风险比，0.96；95%CI，0.79-1.16）。在接受即时检测呼吸道病原体的多重 PCR 的 12 名儿童（1.4%）和对照组的 2 名儿童（0.5%）中开始了针对性抗生素治疗（风险比，3.0；95%CI，0.76-11.9）。两组之间的诊断性检测数量和成本没有差异。
在这项随机临床试验中，即时检测呼吸道病原体并未减少儿科 ED 抗生素的使用。呼吸道病原体检测似乎对急性病儿童的临床决策影响有限。
ClinicalTrials.gov 标识符：NCT03932942。
