Identifying biomarkers linked to severity in adults with RSV infections
Official title: Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus
Run by Assistance Publique - Hôpitaux de Paris · NCT06197152 · Data updated 2026-11-12
This study is trying to find specific markers in the body that can help doctors understand how severe Respiratory Syncytial Virus (RSV) infections are in adults who are hospitalized.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 133 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | November 27, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 9, 2024 |
| Trial ID | NCT06197152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old who are hospitalized with confirmed RSV infections and exhibit clinical signs of lower respiratory tract infection.
✕Probably not a fit
Patients with co-infections from other respiratory viruses or those under guardianship may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify and clinically validate biomarkers associated with the severity of Respiratory Syncytial Virus (RSV) infections in adults. It focuses on patients over 18 years old who are hospitalized with clinical signs of lower respiratory tract infection and have tested positive for RSV via RT-PCR. The study involves collecting nasopharyngeal swabs and biological samples to analyze the relationship between viral load, viral subtypes, and clinical outcomes. The findings could enhance understanding of RSV severity and inform treatment strategies.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of RSV infections in adults, potentially reducing morbidity and mortality.
How similar studies have gone: While there is limited data on the specific biomarkers for RSV severity, similar studies have shown promise in identifying viral load correlations with clinical outcomes in respiratory infections.
Who can join: the full rules
Show full inclusion / exclusion criteria
Group of patients with RSV diagnosis Inclusion Criteria: * Age \> 18 years * Positive RSV RT-PCR in nasopharyngeal swab * Patient admitted to the hospital (intensive care unit or medical ward admission at inclusion) with clinical signs of lower respiratory tract infection (defined as the presence of two or more respiratory signes (cough, dyspnea, sputum production, wheezing, tachypnea (respiratory rate\>20/min) or one respiratory sign plus one or more systemic symptoms (fatigue and fever)) requiring hospitalization. * No objection letter (from the patient or a member of family if the patient is not physically able to give consent Exclusion Criteria: * Co-infection with other respiratory viruses * Persons under guardianship/guardianship * AME (state medical aid) patient Group of "control" patients Inclusion Criteria : * Age\>18 years * Patient's consent * Enrolled in a social security plan * Admitted for an acute respiratory syndrome * No diagnosis of respiratory infection in the 4 weeks prior to inclusion * Negative RSV nasopharyngeal PCR (or other respiratory specimen) collected within the last 48 hours * No immunosuppression (HIV infection, bone marrow or solid organ transplantation, post-chemotherapy aplasia, immunosuppressive therapy, corticosteroid therapy (\> 200 mg/d hydrocortisone or equivalent within 4 weeks prior to inclusion) Exclusion Criteria : * Persons under guardianship/guardianship * AME (state medical aid) patient
Where it's running
-
Intensive Care Unit Henri Mondor APHP
Créteil, France Recruiting
Study contacts
- Study coordinator: Nicolas de Prost, MD, PhD
- Email: nicolas.de-prost@aphp.fr
- Phone: (+33) 1 49 81 23 94
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ziresovir (AK0529) for high-risk adults with RSV infection
This study tests whether Ziresovir can shorten RSV-related lower respiratory tract illness in high-risk adults compared with placebo.
-
Recombinant RSV Vaccine (CHO Cell) with Adjuvant in Adults 18+ in China
This is a two-part study testing a recombinant RSV vaccine in adults to see if it is safe and whether it provokes an immune response, with older adults (60+) included in the second part.
-
RSV strains and illness burden in Vietnamese adults aged 60 and older
This project will test how common RSV is and which strains and severity patterns occur in people aged 60+ who are hospitalized with acute respiratory illness or worsening heart/lung disease.
-
S-337395 for high-risk adults with symptomatic RSV
This trial will test whether taking the antiviral S-337395 within 72 hours of symptoms helps nonhospitalized adults with RSV who are at high risk of progressing to severe illness.
-
Evaluating a new treatment to prevent severe COVID-19 complications
This study is testing a new treatment to see if it can help hospitalized COVID-19 patients avoid severe complications caused by inflammation.
-
Inhaled interferon α1b treatment for RSV in young children
This study is testing a new inhaled treatment for RSV in young children under 2 years old to see if it helps them get better and is safe to use.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.