Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Objective: The main goal of the present study is to identify and validate biomarkers associated with RSV severity in adults infected with RSV that will be useful to guide treatment decisions in the future. This study will additionally characterize the thus far unknown genetic diversity of RSV in hospitalized adults with severe and mild infections, in order to anticipate virological escape mechanisms from current and future treatments. Method: This is a prospective multicenter cohort study of patients with RSV infection admitted to the hospital. These patients will be followed-up for 28 days. Nasopharyngeal samples will be obtained sequentially (i.e., at day 0, day 3-4, day 5-7, and day 14 of inclusion) for virological and transcriptomic analyses. Blood samples will also be collected at day 0 (EDTA tubes and Paxgene tubes) for peripheral transcriptomic analyses and plasma banking. The 100 first patients included in the study will be allocated to the development cohort and the last 100 patients will be allocated to the validation cohort.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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)

Locations
Other Locations
France
Intensive Care Unit Henri Mondor APHP
RECRUITING
Créteil
Contact Information
Primary
Nicolas de Prost, MD, PhD
nicolas.de-prost@aphp.fr
(+33) 1 49 81 23 94
Backup
Slim Fourati, MD, PhD
slim.fourati@aphp.fr
(+33) 1 45 17 81 45
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 133
Treatments
100 patients with RSV diagnosis
Patients with acute respiratory infection and positive nasopharyngeal PCR or other respiratory specimen for RSV.
33 control patients
Patient admitted for acute respiratory syndrome with no diagnosis of respiratory infection or immunosuppression.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov