Disease Burden of RSV

NCT05506670 | Completed

• 1 other identifier: 69HCL22_0703
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

Brief Summary

Respiratory diseases are one of the leading causes of morbidity and mortality among young children, and respiratory syncytial virus (RSV) is the most common pathogen causing these respiratory diseases in this age group. RSV can present in the form of a variety of clinical syndromes, including upper respiratory tract infections, bronchiolitis, pneumonia, exacerbations of asthma and viral-induced wheeze. RSV is highly seasonal and occurs mostly during winter seasons in temperate climates. Sixty to seventy percent of all children experience an RSV infection before the age of one, and nearly all do so before the age of two.( 'Burden of disease' is a general term without a universally accepted definition and refers to the human and economic costs that result from poor health. RSV 'burden of disease' studies in young children (aged 0-4 years), have mostly been focused on the morbidity and mortality rates of RSV infections. The socio-economic burden of RSV infections in young children has been studied, however, a meta-analysis showed that of the 365,828 RSV disease episodes included in cost-analysis studies, only 27,286 (7.4%) focused on outpatient and emergency cases. To our knowledge, only two outpatient studies have prospectively investigated the clinical and socio-economic burden of laboratory confirmed RSV infections in young children; and both studies collected data in the early 2000s. More recently, one study has investigated the health care use, duration of illness and complications associated with RSV in a cohort of newborn infants. There is therefore a lack of knowledge on the clinical and socio-economic disease burden of RSV infections in young children in primary care. Current treatment options for RSV infections are limited to supportive care. The only available antiviral monoclonal antibody (mAb) 'Palivizumab' is considered cost-effective for certain high-risk group infants and requires monthly injections during winter. New candidate RSV vaccines and mAbs (with longer half-life times) are in late-stage clinical trials. Therefore, accurate estimates of the burden of RSV infections, including in primary care, are crucial to better assess the overall impact RSV infections may have on the society.

Conditions

RSV Acute Respiratory Infection

Keywords

RSV infection; pediatrics; clinical burden; socio economic burden

Outcome Measures

Primary Outcomes (2)

• Clinical burden of RSV acute respiratory infections

  Persistent symptomatology at D14

  Day 14

• Clinical burden of RSV acute respiratory infections

  Persistent symptomatology at D30

  Day 30

Study Arms (2)

proved RSV infection (RSV positive patients

EXPERIMENTAL

Other: Diagnostic test and phone call; Diagnostic Test: Diagnostic test

suspected but not proved RSV infection (RSV negative patients)

EXPERIMENTAL

Other: Diagnostic test and phone call; Diagnostic Test: Diagnostic test

Interventions

Diagnostic test and phone call OTHER

Viral diagnostic test will be performed at inclusion. In case of RSV positive results, follow up phone calls will be scheduled at day 14 and day 30 to collect data.

proved RSV infection (RSV positive patients; suspected but not proved RSV infection (RSV negative patients)

Diagnostic test DIAGNOSTIC_TEST

Viral diagnostic test will be performed at inclusion. In case of RSV negative result, no more intervention will be required.

proved RSV infection (RSV positive patients; suspected but not proved RSV infection (RSV negative patients)

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \<5 years
• Consulting a primary care practitioner with symptoms of an acute respiratory infection (ARI)
• Participation agreement of at least one of the two parents/legal guardians before intervention
• Follow-up criterion
• \) Sampled children with a lab-confirmed diagnosis of RSV.

You may not qualify if:

• Signs of severity (moderate to severe respiratory distress, oxygen saturation SpO2 \< 92%, dehydration, Glasgow \< 13) for children \< 3 month-old in emergency department
• No consultation with a doctor in the previous 24 hours
• Insufficient knowledge about the national language by the parents/legal guardians
• Intellectual disabilities of the parents/legal guardians
• Special personal circumstances in the family (based on the judgement of the primary care physician e.g. a recent death in the family)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Centre d'Investigation Clinique de Lyon- Groupement Hospitalier Est- Hospices Civils de Lyon

Bron, Rhone, 69500, France

Location

Maison Médicale de l'Enfant

Écully, Rhone, 69130, France

Location

Cabinet CAPELLI

Lyon, Rhone, 69008, France

Location

Maison Médicale de l'Enfant

Écully, Rhône, 69130, France

Location

Cabinet Bellemin

Villeurbanne, Rhône, 69100, France

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: December 15, 2022
• Primary Completion: February 24, 2024
• Study Completion: February 24, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)