RSV InfectionTwinSeVeRSNCT05070975
Severity of RSV Infections in Twins
An observational study of RSV Infection and Bronchiolitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for… Read more about this study
- Who is it for?
- Ages Up to 354 days
- Conditions the study is for
- RSV Infection, Bronchiolitis
- What is being tested?
- Epidemiology
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2021to 27 Jan 2022
- Phase
- Observational
- 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 Up to 354 days
- All sexes
- No healthy volunteers
- Child
Study population: Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection
Who may be able to join
- Twins born at Hospices Civils de Lyon in the years 2012 to 2020
- At least one twin hospitalized with positive RSV-PCR during the first year of life
Who cannot join
- Major differential underlying disease between twins
- Death of a twin before the RSV epidemic period of the first year of life
- Nosocomial infection
- Lack of understanding of the study or questionnaire by parents
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotype Severity of RSV-infections in Twins During the First Year of Life
Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.
- Conditions
- RSV Infection, Bronchiolitis
- Being tested
- Epidemiology
- Keywords
- RSV infections in twins, Bronchiolitis, very-severe-LRTI, severe-LRTI, LRTI, upper respiratory tract infection, RSV infection, Human, infant
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidemiologyOther
Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.
| Study group | Role | What they receive |
|---|---|---|
| Twins | Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection Receives: Other: Epidemiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.
The primary outcome measure is the percentage of discordant twin pairs of at least one severity level on the WHO (World Health Organization) scale.
The discrepancy in the level of severity is obtained by retrospective analysis of the data from the medical file.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start5 Nov 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 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
- NCT05070975
- Sponsor's protocol ID
- 69HCL21_0634
- Acronym
- TwinSeVeRS
- Status last verified
- Jul 2022
- First submitted
- 27 Sep 2021
- Last updated
- 6 Jul 2022
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype Severity of RSV-infections in Twins During the First Year of Life
- ClinicalTrials.gov ID
- NCT05070975
- Acronym / sponsor ID
- TwinSeVeRS / 69HCL21_0634
- Conditions
- RSV Infection, Bronchiolitis
- Keywords
- RSV infections in twins, Bronchiolitis, very-severe-LRTI, severe-LRTI, LRTI, upper respiratory tract infection, RSV infection, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 7 Oct 2021 (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 syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twins | – | Other: EpidemiologyTwins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection |
Who may qualify
- Ages
- Up to 354 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection
Key inclusion criteria (2 listed)
- Twins born at Hospices Civils de Lyon in the years 2012 to 2020
- At least one twin hospitalized with positive RSV-PCR during the first year of life
Key exclusion criteria (5 listed)
- Major differential underlying disease between twins
- Death of a twin before the RSV epidemic period of the first year of life
- Nosocomial infection
- Lack of understanding of the study or questionnaire by parents
- Lack of parental consent
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 |
|---|---|---|
| EpidemiologyAssessment of the discrepancy of clinical severity of RSV-infections between twin infants. | Other | Twins |
Primary outcome
Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.
Time frame: 1 day
The primary outcome measure is the percentage of discordant twin pairs of at least one severity level on the WHO (World Health Organization) scale. The discrepancy in the level of severity is obtained by retrospective analysis of the data from the medical file.
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 6 Jul 2022.
- Individual participant dataSharing planned: No
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RSV
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.
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 RSV Infection and Bronchiolitis, run by Hospices Civils de Lyon 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 2 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 6 Jul 2022. 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?
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?
Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections. (time frame: 1 day). 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 6 Jul 2022.