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Assessment of the Type I IFN Response in the Nasal Cavity During Respiratory Viral Infections in a Geriatric Department (RESPIGERIA)

2026年5月15日 更新者:Hospices Civils de Lyon

The diagnosis of respiratory viral infections is usually based on testing for pathogens suspected of causing the infection using PCR tests that target the pathogens' DNA or RNA. A specific PCR test is required for each pathogen. In most cases, testing is carried out primarily for three specific viruses (SARS-CoV-2, respiratory syncytial virus (RSV), influenza virus) is carried out as a first-line test. However, numerous viruses can cause these infections (adenovirus, metapneumovirus, rhinovirus, parainfluenza virus, bocavirus, etc.). Consequently, performing a specific PCR test for every virus that could cause respiratory symptoms is not feasible, and viral infections are often under-diagnosed because the screening for viruses is not exhaustive.

To address this issue, analysing the host response to determine the microbial aetiology of an infection may represent an innovative alternative for the diagnosis of infections. A common feature of all viruses is their ability to induce type I interferons (IFN-I). Thus, measuring this IFN-I response could help direct the diagnosis of respiratory infections towards a viral origin.

Furthermore, the detection of a virus via PCR in a respiratory sample may indicate an active or recent infection, but may also be detected following an infection that occurred several weeks or months earlier. The viral load in the sample is an important factor in distinguishing between these two scenarios but does not always allow for a definitive conclusion (some patients may have low viral loads whilst still having an active infection). It is therefore sometimes difficult to distinguish, using a PCR test that detects the viral genome, between the virus currently replicating and traces of viral genetic material from dead viruses. It is therefore necessary to have markers that can be associated with an active/replicating infection to aid interpretation in the event of a positive PCR result.

Using nasopharyngeal swabs collected for the diagnosis of SARS-CoV-2 infection, we were able to demonstrate that it is possible to measure the IFN-I response. These proteins, which possess antiviral properties, are secreted by immune cells during infection to limit viral replication.

Thus, the combination of simultaneous testing for the pathogen and the IFN response has made it possible to link the replicative nature of the SARS-CoV-2 virus with IFN-I production.

Our latest research into SARS-CoV-2 has thus led to the identification of a marker of the IFN-I response associated with active viral replication, which we have confirmed using viral culture techniques that detect only live/infectious virus.

However, the IFN-I response may be compromised in older and very old individuals, particularly due to certain comorbidities or treatments, the prevalence of which increases with age.

The aim of this study is to assess the IFN-I response in the context of respiratory infections caused by various viruses, in a population admitted to a geriatric ward and a population from the REFIPA protocol (NCT07239830), a study designed to establish reference values for nasal and blood interferon scores in uninfected elderly subjects.

There is a need to improve the diagnosis of viral infections, particularly in geriatric wards where the burden of viral infections is very significant for patients, carers and the organisation of care. Rapid diagnosis of viral infections would enable the optimisation of isolation measures and hygiene protocols within these wards. Furthermore, it is important to validate new markers that could aid in the interpretation of a positive PCR result for respiratory viruses. Some PCR tests can indeed remain positive for several weeks or even months due to the detection of traces of viral genetic material.

Thus, new markers indicating an active or recent infection could be useful in facilitating interpretation, alongside other clinical and/or virological findings.

The aim is, by combining different results, to improve the diagnosis of viral infections and to avoid over-diagnosing respiratory viral infections due to a positive PCR result that may in fact correspond to a past infection.

研究概览

研究类型

观察性的

注册 (估计的)

1140

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Lyon、法国、69310
        • 招聘中
        • Hopital Lyon Sud

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This study focuses on nasopharyngeal swabs taken as part of clinical care to screen for respiratory viruses in patients admitted to geriatric wards, or as part of the REFIPA protocol (NCT07239830) in older, asymptomatic, non-hospitalised participants. For hospitalised patients, first-line microbiological tests (RSV, SARS-CoV-2 and influenza) as well as viral culture are carried out as part of routine diagnostic testing. For participants in the REFIPA protocol (NCT07239830), samples were collected as part of this study.

Thus, all samples are collected as part of standard care in hospitalised patients in geriatric wards presenting with signs of respiratory distress, or as part of the REFIPA protocol in asymptomatic, non-hospitalised elderly participants.

The IFN-I score and the results of second-line tests will not be disclosed to the patient's doctor. They will therefore have no impact on the patient's treatment.

描述

Inclusion Criteria:

  • Patients admitted to a geriatric ward or participants diagnosed with a PCR-positive infection based on a swab sample taken as part of the REFIPA study (NCT07239830). Nasopharyngeal swab taken for viral detection, where the viral test was carried out as part of standard clinical care (minimum 500 µL required)

Exclusion Criteria:

  • The patient's objection to the use of their data in this study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Respiratory viral infection geriatric patients

Nasopharyngeal swabs taken from patients admitted to geriatric wards with suspected respiratory viral infection will be selected by the Regional Biological Reference Centres (CRBs). As part of clinical care, the detection of a respiratory virus relies on a first-line diagnostic test. The IFN-I response can be analysed using these same samples, without the need for additional collection.

Furthermore, the ability of the IFN-I response to detect replicating viruses can be tested using viral culture results.

The IFN-I score will be determined from samples tested for the viruses targeted in the first-line testing (influenza, SARS-CoV-2 and RSV) or from samples tested as part of the REFIPA protocol (NCT07239830). A positive score is defined as a threshold > 2.47.

The diagnosis of respiratory viral infection will be established based on a positive result from at least one of the three first-line PCR tests for viruses performed on nasopharyngeal swabs, considered as reference tests or as part of the REFIPA study (NCT07239830).

Respiratory viral infection geriatric patients from REFIPA study (NCT07239830)
Participants who were withdrawn from the REFIPA study (NCT07239830) following a diagnosis of infection based on a positive PCR result from a swab taken as part of the study

The IFN-I score will be determined from samples tested for the viruses targeted in the first-line testing (influenza, SARS-CoV-2 and RSV) or from samples tested as part of the REFIPA protocol (NCT07239830). A positive score is defined as a threshold > 2.47.

The diagnosis of respiratory viral infection will be established based on a positive result from at least one of the three first-line PCR tests for viruses performed on nasopharyngeal swabs, considered as reference tests or as part of the REFIPA study (NCT07239830).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluate the diagnostic performance of the IFN-I score for detecting respiratory viral infection vs first-line tests (influenza, SARS-CoV-2, RSV) in geriatric patients or REFIPA (NCT07239830) participants withdrawn due to PCR-confirmed infection on study
大体时间:One time

The IFN-I score will be determined from samples tested for the viruses targeted in the first-line testing (influenza, SARS-CoV-2 and RSV) or from samples tested as part of the REFIPA protocol (NCT07239830). A positive score is defined as a threshold > 2.47.

The diagnosis of respiratory viral infection will be established based on a positive result from at least one of the three first-line PCR tests for viruses performed on nasopharyngeal swabs, considered as reference tests or as part of the REFIPA study (NCT07239830).

One time

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月4日

初级完成 (估计的)

2026年5月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 24-5127
  • 69HCL24_0191 (其他标识符:HCL)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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