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临床试验/NCT05765838
NCT05765838招募中不适用

Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
RT-PCR for upper airway viral diagnostics

研究概览

简要总结

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The inclusion criterion:
  • •A. 18 years or more of age requiring a test for COVID-

排除标准

  • •A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
  • •B. Do not understand oral or written Danish

研究组 & 干预措施

Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)

Experimental

1 NPS right - Nasal swab left - OPS

NPS = nasopharyngeal swab OPS = oropharyngeal swab

干预措施: (NPS right - Nasal swab left - OPS) (Diagnostic Test)

Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)

Experimental

2 NPS left - Nasal swab right - OPS

干预措施: (NPS left - Nasal swab right - OPS) (Diagnostic Test)

Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)

Experimental

3 Nasal swab right - NPS left - OPS

干预措施: (Nasal swab right - NPS left - OPS) (Diagnostic Test)

Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)

Experimental

4 Nasal swab left - NPS right - OPS

干预措施: (Nasal swab left - NPS right - OPS) (Diagnostic Test)

Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)

Experimental

5 NPS right - OPS - Nasal swab left

干预措施: (NPS right - OPS - Nasal swab left) (Diagnostic Test)

Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)

Experimental

6 NPS left - OPS - Nasal swab right

干预措施: (NPS left - OPS - Nasal swab right) (Diagnostic Test)

Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)

Experimental

7 Nasal swab right - OPS - NPS left

干预措施: (Nasal swab right - OPS - NPS left) (Diagnostic Test)

Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)

Experimental

8 Nasal swab left - OPS - NPS right

干预措施: (Nasal swab left - OPS - NPS right) (Diagnostic Test)

Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)

Experimental

9 OPS - NPS right - Nasal swab left

干预措施: (OPS - NPS right - Nasal swab left) (Diagnostic Test)

Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)

Experimental

10 OPS - NPS left - Nasal swab right

干预措施: (OPS - NPS left - Nasal swab right) (Diagnostic Test)

Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)

Experimental

11 OPS - Nasal swab left - NPS right

干预措施: (OPS - Nasal swab left - NPS right) (Diagnostic Test)

Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)

Experimental

12 OPS - Nasal swab right - NPS left

干预措施: (OPS - Nasal swab right - NPS left) (Diagnostic Test)

结局指标

主要结局

RT-PCR for upper airway viral diagnostics

时间窗: 1 day

the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B

次要结局

  • local immunological mediators from the upper airway tract(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tobias Todsen

MD, Phd, Consultant, Ass. Prof

Rigshospitalet, Denmark

研究点 (1)

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