NCT06197152 Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV
| NCT ID | NCT06197152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Respiratory Syncytial Virus Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 133 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 133 participants in total. It began in 2023-11-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 infection (LRTI) in infants and also causes significant morbidity and mortality in adults, especially in the elderly, in patients with cardiorespiratory comorbidities \[e.g., patients with Chronic Obstructive Pulmonary Disease (COPD) and/or heart failure\], and in immunocompromised patients. Clinical phenotyping of RSV respiratory infections has shown that the occurrence of LRTI in RSV-infected patients is associated with the need for ventilatory support and an increased risk of mortality. Virological data also suggest that there is a relationship between high nasopharyngeal viral replication levels and a poor prognosis, although these data have not been confirmed in other studies. Beyond viral load, the impact of viral subtypes on the severity of RSV infection is controversial. Few data have explored the prognostic value of genetic diversity (i.e., role of RSV variants, mutations occurring during clinical course) in RSV-infected adult patients with acute respiratory failure. 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 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
Contact & Investigator
Pierre-André Natella, PhD
STUDY CHAIR
APHP URC
Frequently Asked Questions
Who can join the NCT06197152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Syncytial Virus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06197152 currently recruiting?
Yes, NCT06197152 is actively recruiting participants. Contact the research team at nicolas.de-prost@aphp.fr for enrollment information.
Where is the NCT06197152 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06197152 clinical trial?
NCT06197152 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Pierre-André Natella, PhD at APHP URC. The trial plans to enroll 133 participants.