Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 26, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how severe Respiratory Syncytial Virus (RSV) infections are in adults and identifying specific markers, called biomarkers, that can help predict the severity of the illness. RSV is a common virus that can lead to serious respiratory infections, especially in older adults and those with existing health issues like lung or heart conditions. By studying the biological samples from hospitalized patients, the researchers aim to find patterns that could help doctors make better treatment decisions in the future.
To participate in this study, individuals must be over 18 years old and have a confirmed RSV infection through a nasal swab test, along with symptoms that require hospitalization. Patients will be followed for 28 days with regular check-ins and sample collections. It's important to note that patients who have other respiratory infections will not be eligible. By taking part in this trial, participants may help contribute to important research that could improve care for others affected by RSV in the future.
Gender
ALL
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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Créteil, , France
Patients applied
Trial Officials
Pierre-André Natella, PhD
Study Chair
APHP URC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported