RSV Acute Respiratory InfectionRSV ComNet IIINCT05506670
Disease Burden of RSV
A study testing Diagnostic test and phone call and Diagnostic test in people with RSV Acute Respiratory Infection, run by Hospices Civils de Lyon at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- RSV Acute Respiratory Infection
- What is being tested?
- Diagnostic test and phone call and Diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Dec 2022to 24 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre d'Investigation Clinique de Lyon- Groupement Hospitalier Est- Hospices Civils de Lyon
Bron, Rhone, 69500
Maison Médicale de l'Enfant
Écully, Rhone, 69130
Maison Médicale de l'Enfant
Écully, Rhône, 69130
Cabinet CAPELLI
Lyon, Rhone, 69008
Cabinet Bellemin
Villeurbanne, Rhône, 69100
About this study
Official title: Disease Burden of RSV in Young Children in Primary Care
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
- Being tested
- Diagnostic test and phone call, Diagnostic test
- Keywords
- RSV infection, pediatrics, clinical burden, socio economic burden
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test and phone callOther
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.
Diagnostic testDiagnostic test
Viral diagnostic test will be performed at inclusion. In case of RSV negative result, no more intervention will be required.
| Study group | Role | What they receive |
|---|---|---|
| proved RSV infection (RSV positive patients | Experimental | Not described Receives: Other: Diagnostic test and phone call; Diagnostic Test: Diagnostic test |
| suspected but not proved RSV infection (RSV negative patients) | Experimental | Not described Receives: Other: Diagnostic test and phone call; Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical burden of RSV acute respiratory infections
Persistent symptomatology at D14
Measured: Day 14
Clinical burden of RSV acute respiratory infections
Persistent symptomatology at D30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start15 Dec 2022
- Primary completion24 Feb 2024
- Study completion24 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV Acute Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506670
- Sponsor's protocol ID
- 69HCL22_0703
- Acronym
- RSV ComNet III
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Burden of RSV in Young Children in Primary Care
- ClinicalTrials.gov ID
- NCT05506670
- Acronym / sponsor ID
- RSV ComNet III / 69HCL22_0703
- Conditions
- RSV Acute Respiratory Infection
- Keywords
- RSV infection, pediatrics, clinical burden, socio economic burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 24 Feb 2024 (actual)
- First posted
- 18 Aug 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Diagnostic test and phone callViral 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. | Other | proved RSV infection (RSV positive patients, suspected but not proved RSV infection (RSV negative patients) |
| Diagnostic testViral diagnostic test will be performed at inclusion. In case of RSV negative result, no more intervention will be required. | Diagnostic test | proved RSV infection (RSV positive patients, suspected but not proved RSV infection (RSV negative patients) |
Primary outcome
Clinical burden of RSV acute respiratory infections
Time frame: Day 14
Persistent symptomatology at D14
Clinical burden of RSV acute respiratory infections
Time frame: Day 30
Persistent symptomatology at D30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test and phone call and Diagnostic test in people with RSV Acute Respiratory Infection, run by Hospices Civils de Lyon at 5 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical burden of RSV acute respiratory infections (time frame: Day 14). The study lists 2 primary outcomes in all. 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 8 Jul 2024.