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Disease Burden of RSV (RSV ComNet III)

Primary Purpose

RSV Acute Respiratory Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic test and phone call
Diagnostic test
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for RSV Acute Respiratory Infection focused on measuring RSV infection, pediatrics, clinical burden, socio economic burden

Eligibility Criteria

0 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age <5 years
  2. Consulting a primary care practitioner with symptoms of an acute respiratory infection (ARI)
  3. Participation agreement of at least one of the two parents/legal guardians before intervention

Follow-up criterion

1) Sampled children with a lab-confirmed diagnosis of RSV.

Exclusion Criteria:

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

Sites / Locations

  • Centre d'Investigation Clinique de Lyon- Groupement Hospitalier Est- Hospices Civils de LyonRecruiting
  • Maison Médicale de l'Enfant
  • Cabinet Bellemin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

proved RSV infection (RSV positive patients

suspected but not proved RSV infection (RSV negative patients)

Arm Description

Outcomes

Primary Outcome Measures

Clinical burden of RSV acute respiratory infections
Persistent symptomatology at D14
Clinical burden of RSV acute respiratory infections
Persistent symptomatology at D30

Secondary Outcome Measures

Full Information

First Posted
August 12, 2022
Last Updated
July 17, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05506670
Brief Title
Disease Burden of RSV
Acronym
RSV ComNet III
Official Title
Disease Burden of RSV in Young Children in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Acute Respiratory Infection
Keywords
RSV infection, pediatrics, clinical burden, socio economic burden

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
proved RSV infection (RSV positive patients
Arm Type
Experimental
Arm Title
suspected but not proved RSV infection (RSV negative patients)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diagnostic test and phone call
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic test
Intervention Description
Viral diagnostic test will be performed at inclusion. In case of RSV negative result, no more intervention will be required.
Primary Outcome Measure Information:
Title
Clinical burden of RSV acute respiratory infections
Description
Persistent symptomatology at D14
Time Frame
Day 14
Title
Clinical burden of RSV acute respiratory infections
Description
Persistent symptomatology at D30
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 1) Sampled children with a lab-confirmed diagnosis of RSV. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie PORTEFAIX, Dr
Phone
04.72.35.79.99
Ext
+33
Email
aurelie.portefaix@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tiphanie GINHOUX
Phone
04.27.85.77.23
Ext
+33
Email
tiphanie.ginhoux@chu-lyon.fr
Facility Information:
Facility Name
Centre d'Investigation Clinique de Lyon- Groupement Hospitalier Est- Hospices Civils de Lyon
City
Bron
State/Province
Rhone
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie PORTEFAIX, DR
Phone
04.72.35.79.99
Ext
+33
Email
aurelie.portefaix@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Tiphanie GINHOUX
Phone
04.27.85.77.23
Ext
+33
Email
tiphanie.ginhoux@chu-lyon.fr
Facility Name
Maison Médicale de l'Enfant
City
Ecully
State/Province
Rhône
ZIP/Postal Code
69130
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Lison BARBIER, Dr
Phone
04 72 19 34 81
Ext
+33
Email
mlisonbarbier@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marie-Lison BARBIER, Dr
Facility Name
Cabinet Bellemin
City
Villeurbanne
State/Province
Rhône
ZIP/Postal Code
69100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Bellemin, Dr
Phone
04 78 84 21 22
Ext
+33
Email
ka.bellemin@gmail.com
First Name & Middle Initial & Last Name & Degree
Karine Bellemin, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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