RecruitingOBSERVATIONAL

Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV

This research aims to understand why Respiratory Syncytial Virus (RSV) affects adults differently, with some experiencing mild symptoms and others becoming very ill. We know RSV is a frequent cause of breathing problems, especially in older adults and those with existing heart or lung conditions. This study will look at biological clues, called biomarkers, from nose swabs and blood samples to see if there are patterns that can predict how severe someone's RSV infection will be. By identifying these markers, doctors hope to make better treatment decisions in the future and develop new ways to fight the virus. The study also explores the different types of RSV to understand how the virus changes and potentially escapes treatments.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

133

Start

27 Nov 2023

Estimated completion

01 Dec 2026

Respiratory Syncytial Virus Infections

What is this study about?

This research project is all about understanding why some adults get very sick with Respiratory Syncytial Virus (RSV) while others only experience mild cold-like symptoms. RSV is a common winter virus that can cause chest infections, especially in babies, but it also causes significant problems for adults, particularly older people or those with conditions like asthma, COPD, or heart failure. We know that severe RSV can lead to needing hospital care, and sometimes even intensive care.

The main goal of this study is to find specific 'markers' in the body that can tell us early on if someone is likely to have a severe RSV infection. Think of these markers as early warning signs. Researchers will look for these clues in samples taken from patients, such as nose swabs and blood. If successful, these findings could help doctors make quicker and more informed decisions about treatment, potentially preventing patients from becoming more seriously ill. It could also guide the development of new and more effective medicines.

Additionally, the study will look closely at the virus itself within different patients. By examining the genetic makeup of RSV in both mildly and severely ill patients, researchers hope to learn how the virus changes and adapts. This information is really important for developing new treatments and vaccines that can stay ahead of the virus, making them more effective in the long run. Understanding these changes helps us better prepare for future challenges from RSV.

Key takeaways

This study aims to find markers that predict RSV severity in adults.
It will help improve future treatment decisions for RSV.
Participation involves providing nose swabs and blood samples over 28 days.
Your regular medical care will not be affected by joining the study.
The research helps understand how RSV changes and adapts.
Your contribution could lead to better outcomes for others with RSV.

Who may be eligible?

This study is looking for two main groups of people: adults who have been diagnosed with RSV and are in hospital due to breathing problems, and a 'control' group of adults who are in hospital for other acute breathing issues but do NOT have RSV.

For those with RSV, you must be over 18, have a confirmed RSV infection from a nose swab, and be in hospital because of a chest infection (like a cough, breathlessness, or wheezing). You'll also need to be able to agree to take part, or have a family member agree for you if you're too unwell.

The control group also needs to be over 18, agree to take part, and be in hospital for an acute breathing problem. However, importantly, you must NOT have RSV (confirmed by a negative test) and should not have had any respiratory infection in the past four weeks. You also shouldn't have a weakened immune system, for example, due to certain illnesses or medications. The study won't include anyone with other respiratory viruses at the same time as RSV, or those under legal guardianship or receiving specific state medical aid that impacts participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Have you been diagnosed with RSV and are currently in hospital for a chest infection?
Are you able to agree to take part, or can a family member agree for you?
Do you not have any other respiratory viruses at the same time as RSV?
Alternatively, are you over 18, in hospital for breathing problems, but tested negative for RSV?
Do you have a healthy immune system?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed for 28 days. During this time, the research team will collect some samples from you. This includes nose swabs taken at various points: when you first join the study, then around day 3-4, day 5-7, and finally around day 14. These swabs will help researchers look at the virus and other cellular details.

You will also have blood samples collected when you first join the study. These blood samples will be used to look for specific markers in your blood and some will be stored for future research. No medication will be given to you as part of this study; it's purely observational, meaning researchers are just collecting information and samples to understand more about RSV. Your regular treatment will continue as normal.

Potential risks and benefits

Taking part in this study won't change your medical treatment and aims to help future patients, but it's important to understand what's involved. The main benefit is contributing valuable information that could lead to better ways of diagnosing and treating serious RSV infections in the future. The risks involve minor discomfort from blood draws and nose swabs, similar to routine medical tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Intensive Care Unit Henri Mondor APHP
Verified postcode
Créteil, France· Recruiting

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that causes breathing problems, often like a cold, but can lead to more serious chest infections, especially in babies, older people, and those with certain health conditions.

What are 'biomarkers'?

Biomarkers are like clues found in your body, such as in blood or nose swabs. Researchers hope these clues can tell them if someone with RSV is likely to get very sick or not.

Will taking part in the study change my treatment?

No, taking part in this study will not change your medical treatment. You will receive the standard care your doctors recommend, and the study is just collecting information and samples.

How long will I be involved in the study?

You will be followed for 28 days from when you join the study, during which samples will be collected at different times.

What happens to my samples?

Your nose swabs and blood samples will be analysed to look for markers related to RSV severity and to study the virus itself. Some blood samples may also be stored for possible future research.

How to find out more

Nicolas de Prost, MD, PhD

nicolas.de-prost@aphp.fr (+33) 1 49 81 23 94 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.