Identifying biomarkers linked to severity in adults with RSV infections
Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus
Assistance Publique - Hôpitaux de Paris · NCT06197152
This study is trying to find specific markers in the body that can help doctors understand how severe Respiratory Syncytial Virus (RSV) infections are in adults who are hospitalized.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06197152 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and clinically validate biomarkers associated with the severity of Respiratory Syncytial Virus (RSV) infections in adults. It focuses on patients over 18 years old who are hospitalized with clinical signs of lower respiratory tract infection and have tested positive for RSV via RT-PCR. The study involves collecting nasopharyngeal swabs and biological samples to analyze the relationship between viral load, viral subtypes, and clinical outcomes. The findings could enhance understanding of RSV severity and inform treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are hospitalized with confirmed RSV infections and exhibit clinical signs of lower respiratory tract infection.
Not a fit: Patients with co-infections from other respiratory viruses or those under guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of RSV infections in adults, potentially reducing morbidity and mortality.
How similar studies have performed: While there is limited data on the specific biomarkers for RSV severity, similar studies have shown promise in identifying viral load correlations with clinical outcomes in respiratory infections.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil
- Intensive Care Unit Henri Mondor APHP — Créteil, France (RECRUITING)
Study contacts
- Study coordinator: Nicolas de Prost, MD, PhD
- Email: nicolas.de-prost@aphp.fr
- Phone: (+33) 1 49 81 23 94
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus, RSV, Respiratory infection, Febrile acute respiratory syndrome, Immuno-virological determinants