Actively Recruiting
Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-01-09
133
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Respiratory Syncytial Virus (RSV) is a common cause of respiratory infections and is a leading viral cause of lower respiratory tract infection in infants. It also causes significant illness and death in adults, especially older adults, people with heart or lung diseases, and those with weakened immune systems. Researchers are studying how different RSV viral factors and genetic variations affect the severity of infection in hospitalized adults to help guide future treatment decisions. This observational study aims to identify and confirm biomarkers linked to severe RSV infection and to understand the virus's genetic diversity during illness. The study follows adults hospitalized with RSV infection for up to 28 days. Participants will have nasopharyngeal swabs collected at several times: on the day of inclusion, days 3-4, days 5-7, and day 14. Blood samples will also be taken at the start for detailed immune and genetic testing. The first 100 patients will form a development group and the last 100 patients a validation group. A control group of patients admitted with acute respiratory symptoms but without RSV infection will also be included. During the study, researchers will analyze immune and inflammatory responses within the first 72 hours of hospital admission and throughout the stay up to 28 days. They will also study RSV genetic changes during hospitalization. Patients will be monitored closely through sample collections and clinical assessments. The main goal is to better understand how RSV infection progresses in adults and identify signs that predict severity, helping to improve future care and treatments.
CONDITIONS
Brief Title
Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Positive RSV RT-PCR in nasopharyngeal swab
- Hospital admission with clinical signs of lower respiratory tract infection requiring hospitalization
- No objection to participation from patient or family if patient cannot consent
- For control group: age over 18 years, consent given, enrolled in social security plan, admitted for acute respiratory syndrome with no respiratory infection diagnosis in prior 4 weeks, negative RSV PCR within last 48 hours, no immunosuppression
You will not qualify if you...
- Co-infection with other respiratory viruses
- Persons under guardianship or unable to provide consent
- AME (state medical aid) patients
- For control group: persons under guardianship or AME patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 72 hours of hospitalization
Participants undergo nasopharyngeal swabs and biological sample collection for RSV detection and biomarker identification.
1 to 2 visits depending on patient status
Duration - Up to 28 days during hospitalization
Participants are monitored during their hospital stay to assess inflammatory, immune responses, and RSV genetic variability.
Ongoing assessments during hospitalization
Trial Site Locations
Total: 1 location
1
Intensive Care Unit Henri Mondor APHP
Créteil, France, 94010
Actively Recruiting
Research Team
N
Nicolas de Prost, MD, PhD
S
Slim Fourati, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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