Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

Respiratory Syncytial Virus Infections Clinical Trial

— PRSVH  

Official title:

Exploring the Role of Socio Demographic, Clinical Risk Factors, Cord Specific Antibody at Birth, and Virus Characteristic, in Respiratory Syncytial Virus (RSV) in Hospitalized vs Ambulant Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04144816
• Other study ID #: PRSVH_2019
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: October 2020

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: Jean-Sebastien CASALEGNO, MD/PhD
• Phone: 4 72 07 10 23
• Email: jean-sebastien.casalegno[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants.

Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.

Description:

Objective:

To determine the main predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

Study design:

Prospective epidemiological, observational, one-center cohort study with sample collection.

Study population:

Birth cohort of infants born in Lyon before and during the RSV circulation period (October to march) with a follow-up until one year old (from birth until the age of 1 year maximum):

• Estimate Birth cohort (n=5,000).

• Estimate number of RSVH case (n=110).

• Estimate number of Blood cordon associated with a RSVH (Respiratory Syncytial Virus Human) case (n=60)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: October 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Days

Eligibility

Inclusion Criteria:

• Children born alive at participating centers.

• Parents living in the Rhone Alpes Auvergne region

Exclusion Criteria:

• Parents non-willing to participate

• Parents living outside the region

Related Conditions & MeSH terms

• Bronchiolitis
• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• RSV Bronchiolitis
• RSV Infection
• Syncytial Virus Respiratory Infection
• Virus Diseases

Intervention

Other:
• Not applicable (no intervention)
Not applicable (no intervention)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year	Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.	1 year after inclusion
Primary	Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.	Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.	3 years after inclusion
Secondary	Quantitative level of anti-RSV IgG measure	The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)	3 years after inclusion
Secondary	Quantitative level of anti-RSV IgG (Immunoglobulin G) measure	The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)	3 years after inclusion