Respiratory Syncytial Virus InfectionsARF-RSVNCT06197152
Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV
An observational study of Respiratory Syncytial Virus Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Nasopharyngeal swabs and biological collection
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RSV diagnosis : Patients hospitalized for RSV respiratory infection requiring hospital admission. Control group : patients admitted for acute respiratory failure free for RSV or any other infection.
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- Co-infection with other respiratory viruses
- Persons under guardianship/guardianship
- AME (state medical aid) patient
- Group of "control" patients
- Persons under guardianship/guardianship
- AME (state medical aid) patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Intensive Care Unit Henri Mondor APHP
Créteil, 94010
Nicolas DE PROST, MD-PHD, nicolas.de-prost@aphp.fr
PIERRE BAY, MD, pierre.bay@aphp.fr
About this study
Official title: Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus
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.
Read more
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Nasopharyngeal swabs and biological collection
- Keywords
- Respiratory Syncytial Virus, RSV, Respiratory infection, Febrile acute respiratory syndrome, Immuno-virological determinants
- Medical subject headings
- Respiratory Syncytial Virus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabs and biological collectionOther
- Nasopharyngeal PCR
- Blood and virological samples taken as part of the research will be included in a biological collection
| Study group | Role | What they receive |
|---|---|---|
| 100 patients with RSV diagnosis | Patients with acute respiratory infection and positive nasopharyngeal PCR or other respiratory specimen for RSV. Receives: Other: Nasopharyngeal swabs and biological collection | |
| 33 control patients | Patient admitted for acute respiratory syndrome with no diagnosis of respiratory infection or immunosuppression. Receives: Other: Nasopharyngeal swabs and biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory and immune response
Patients with severe disease, defined as developing acute respiratory failure with a World Health Organization (WHO) ten-point scale ≥6 at any time of hospital stay, and those with mild disease (WHO ten-point scale remaining <6 during hospital stay) will be compared using several biological tools, in particular the inflammatory and immune response assessed by transcriptomic analyses in peripheral blood and in respiratory samples (nasopharyngeal swabs and bronchoalveolar lavage fluid or tracheal aspirates when available).
Measured: within 72h of hospitalization
Secondary outcomes (3)
Inflammatory and immune response during hospital stay
Differences between the two groups of RSV-infected patients, with severe disease (WHO ten-point scale ≥6) versus mild disease (WHO ten-point scale remaining <6), of inflammatory and immune responses assessed by transcriptomic analyses in respiratory samples (nasopharyngeal swabs and bronchoalveolar lavage fluid or tracheal aspirates when available).
Measured: during hospitalization (until day 28).
RSV genetic variability during hospitalization
Relationship between viral level dynamics and intra-individual viral genetic variability in respiratory samples (nasopharyngeal swabs and bronchoalveolar lavage fluid or tracheal aspirates when available).
Measured: during hospitalization (until day 28)
RSV genetic variability at admission
Differences between the two groups of RSV-infected patients, with severe disease (WHO ten-point scale ≥6) versus mild disease (WHO ten-point scale remaining <6), of inter-individual viral genetic variability in respiratory samples (nasopharyngeal swabs).
Measured: during hospitalization (within 72h of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start27 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-André Natella, PhD, Study chair, APHP URC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197152
- Sponsor's protocol ID
- APHP221290
- Acronym
- ARF-RSV
- Status last verified
- Nov 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus
- ClinicalTrials.gov ID
- NCT06197152
- Acronym / sponsor ID
- ARF-RSV / APHP221290
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus, RSV, Respiratory infection, Febrile acute respiratory syndrome, Immuno-virological determinants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients with RSV diagnosis | – | Other: Nasopharyngeal swabs and biological collectionPatients with acute respiratory infection and positive nasopharyngeal PCR or other respiratory specimen for RSV. |
| 33 control patients | – | Other: Nasopharyngeal swabs and biological collectionPatient admitted for acute respiratory syndrome with no diagnosis of respiratory infection or immunosuppression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RSV diagnosis : Patients hospitalized for RSV respiratory infection requiring hospital admission. Control group : patients admitted for acute respiratory failure free for RSV or any other infection.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Co-infection with other respiratory viruses
- Persons under guardianship/guardianship
- AME (state medical aid) patient
- Group of "control" patients
- Persons under guardianship/guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabs and biological collection* Nasopharyngeal PCR * Blood and virological samples taken as part of the research will be included in a biological collection | Other | 100 patients with RSV diagnosis, 33 control patients |
Primary outcome
Inflammatory and immune response
Time frame: within 72h of hospitalization
Patients with severe disease, defined as developing acute respiratory failure with a World Health Organization (WHO) ten-point scale ≥6 at any time of hospital stay, and those with mild disease (WHO ten-point scale remaining <6 during hospital stay) will be compared using several biological tools, in particular the inflammatory and immune response assessed by transcriptomic analyses in peripheral blood and in respiratory samples (nasopharyngeal swabs and bronchoalveolar lavage fluid or tracheal aspirates when available).
3 secondary outcomes
Inflammatory and immune response during hospital stay
Time frame: during hospitalization (until day 28).
RSV genetic variability during hospitalization
Time frame: during hospitalization (until day 28)
RSV genetic variability at admission
Time frame: during hospitalization (within 72h of hospitalization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre-André Natella, PhD study chair
APHP URC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas de Prost, MD, PhD ((+33) 1 49 81 23 94, nicolas.de-prost@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory and immune response (time frame: within 72h of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.