跳至主要内容
临床试验/NCT05105191
NCT05105191终止不适用

Analytical Performances and Clinical Impact of the Roche Cobas® Liat Influenza A/B & RSV Assay in the Management of Adult and Pediatric Patients Attending the Emergency Room

Erasme University Hospital4 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
280
试验地点
4
主要终点
Analytical performance (Sensitivity/Specificity)

研究概览

简要总结

Molecular techniques for respiratory virus detection have already shown benefits in terms of sensitivity gained in comparison to conventional techniques. Recent progress has made it possible to shorten turnaround time (TAT) and to allow delivery of results in a timely manner, especially in comparison to cell culture and direct fluorescence assays (DFA). However, the cost of these molecular assays is usually not taken in charge by public health insurance system. This could be partly explained by the fact that molecular techniques have not clearly shown cost-effectiveness. Results of molecular tests for influenza viruses and RSV, if delivered rapidly, in the emergency room (ER), would most likely help avoid antibiotic use and ancillary test prescription, improve antiviral prescription and shorten length of stay in the ward by facilitating discharge or cohorting of hospitalized patients. The goal of this study is to assess the performances of Roche Cobas® Liat Influenza A/B & RSV assay, to appraise its clinical impact and to evaluate its cost effectiveness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Either a pre-test indication of hospitalization
  • or an underlying situation at risk of respiratory complication following influenza infection

排除标准

  • 未提供

结局指标

主要结局

Analytical performance (Sensitivity/Specificity)

时间窗: through study completion, 6 months

Calculation of sensitivity and specificity of the test versus a composite reference standard. Samples are considered as positive for a viral pathogen if testing positive for this viral pathogen by at least 2 of the 3 techniques used, negative if tested negative by at least 2 of the 3 techniques (culture, antigen detection and PCR test).

Hospital admission intentions

时间窗: through study completion, 6 months

Number of admission intentions before and after the test result

Isolation intentions

时间窗: through study completion, 6 months

Number of isolation intentions before and after the test result

Antibiotic prescription intentions

时间窗: through study completion, 6 months

Number of antibiotic prescription intentions before and after the test result

Antiviral treatment prescription intentions

时间窗: through study completion, 6 months

Number of antiviral treatments prescription intentions before and after the test result

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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