NCT06743750已完成不适用
Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
研究概览
简要总结
The goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and adults presenting to an emergency departements with symptoms compatible with respiratory tract infection. The main question it aims to answer is:
- Is the precision of reverse transcription polymerase chain reaction (RT-PCR) for Influenzavirus A or B, respiratory syncytial virus (RSV), and Rhinovirus, on saliva, orobuccal swabs and nasal swabs comparable to the gold standard nasopharyngeal swab in a pediatric and adult population presenting with symptoms compatible with respiratory tract infection.
Among participants the following samples will be collected (nasopharyngeal swab is standard of care and not part of the study samples):
- Saliva
- Orobuccal swab
- Nasal swab
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting at the emergency departments or hospitalized at Inselspital Bern university hospital with any symptom compatible with an acute respiratory tract infection in whom a nasopharyngeal swab to test for respiratory viruses is performed (standard of care)
- •Written informed consent from the trial subject has been obtained; for patients aged 0-13 years, or not able to provide informed consent, consent obtained from the legal representative; for patients between 14-18 years, written informed consent obtained from the respective patient as well as the legal representative.
排除标准
- •Patients unable to provide a saliva (e.g. patients with reduced level of consciousness). Children too young to be instructed to provide saliva are not excluded, but saliva won't be collected.
- •Patients with swallowing disturbances
- •Patient's lack of accountability and inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly AND legal representative not available.
结局指标
主要结局
Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
时间窗: At baseline
Specificity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
时间窗: At baseline
次要结局
- Area under the receiver operating characteristic (ROC) curve for the detection of Influenza A/B, RSV and Rhinovirus in each study sample (orobuccal or nasal swab and saliva).(At baseline)
- Positive agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs.(At baseline)
- Negative agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs.(At baseline)
- Prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.(At baseline)
- Sensitivity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.(At baseline)
- Specificity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.(At baseline)
- Incremental yield of virus detection in orobuccal, nasal and saliva as compared to nasopharyngeal samples.(At baseline)
- Co-prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.(At baseline)
- Association between predefined symptoms and probability for positive RT-PCR of specific viruses using different (nasopharyngeal, orobuccal, nasal, saliva) samples.(At baseline)
- Comparative cycling time values at the different sampling locations(At baseline)
研究者
研究点 (1)
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