Status:
RECRUITING
Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
18+ years
Brief Summary
A short description, 5000 characters Intro: Respiratory Syncytial Virus (RSV) is a frequent, ubiquitous agent of respiratory viral infections. It is the leading viral cause of lower respiratory tract ...
Eligibility Criteria
Inclusion
- Group of patients with RSV diagnosis
- 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
- 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
Key Trial Info
Start Date :
November 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT06197152
Start Date
November 27 2023
End Date
December 1 2026
Last Update
January 9 2024
Active Locations (1)
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1
Intensive Care Unit Henri Mondor APHP
Créteil, France, 94010