Bronchiolitis; Respiratory Syncytial VirusVRS-12NCT04415229
RSV Seasonality in Martinique in Children Aged 2 Years or Less
An observational study of Bronchiolitis; Respiratory Syncytial Virus, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put forward: influence of favorable climatic conditions… Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Bronchiolitis; Respiratory Syncytial Virus
- How many people
- 1,237 participants
- Where
- 1 siteMartinique
- Study dates
- 2 Oct 2019to 12 Apr 2023
- 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 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: children 2 years of age or younger hospitalized in Martinique with RSV bronchiolitis cases, over a 12-year period (2007 to 2018)
Who may be able to join
- two years of age or younger
- hospitalized for bronchiolitis in the pediatrics department of the University hospital of Martinique over the period 2007 to 2018
- with a confirmed virological diagnosis of RSV virus by ImmunoFluorescence (IF) from 01/01/2007 to 31/01/2016 and from 01/02/2016 by Reverse transcription polymerase chain reaction.
- with a clinical diagnosis of bronchiolitis (presentation of suggestive clinical signs such as cough, respiratory distress associated with a febrile illness, with rhinopharyngitis in the previous days)
- no opposition from the legal representative for the use of the data from the medical file in the context of the research. This non-opposition is documented in the patient's medical file
Who cannot join
- opposition from the legal representative for the use of the data from the medical file
- Inability to inform legal representatives of the conduct of the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seasonality of Respiratory Syncytial Virus (RSV) Bronchiolitis in Children Aged 2 Years or Less Hospitalized in Martinique (French West Indies) a Tropical Area From 2007 to 2018
The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put forward: influence of favorable climatic conditions in the month preceding the start of the epidemic. In addition, the study will improve our knowledge of the epidemiology of the infection in order to improve the management of infants.
Read the detailed description
Respiratory Syncytial Virus (RSV) infections are the leading cause of hospitalization for respiratory distress in infants (50% of children under 1 year of age are infected with the virus, 100% of children under 3 years of age). They are responsible for 66,000 to 199,000 deaths in children under 5 years of age worldwide, and 15,000 to 20,000 hospitalizations in France depending on the year. It is a highly contagious virus whose transmission is both respiratory and by hand and which appreciates humidity to develop.
In temperate regions where this infection has been well studied, it occurs preferentially during the winter, probably favoured by the cold and humidity, as well as by the confinement of individuals during this season. The more the child is young, premature, has a chronic respiratory pathology or congenital heart disease, the more sever the disease. Prevention is based on the injection of a monoclonal antibody (Palivizumab) before the start of the epidemic season and on conventional hygiene measures. But today, little epidemiological data is available for tropical regions and in Martinique, which makes it impossible to understand why, how and when RSV develops on our island. Some epidemiological studies carried out in tropical regions point to the possibility that the humidity in the air would favour viral development and in fact, these epidemics are more frequently found during the rainy season. The humidity level, the number of rainy days, the rate of sunshine and cloud cover, and finally the importance of the wind, could explain a different seasonality from that known in temperate regions (seasonality being linked to the virus circulation patterns and being defined as the ability to re-emerge at the same period from one year to the next).
Research issues A first study carried out at the University hospital of Martinique over a period of 2 years (from July 1, 2007 to December 31, 2008) has made it possible to specify the epidemiology a little better but the results need to be confirmed. This work seems to show that the epidemic starts earlier than in temperate zones: (late August - early September to late November - early December) versus (November - December to March - April) respectively. The number of cases per epidemic can change significantly (factor 2.5). However, this first study was not long enough to ensure that the seasonality identified will be systematically repeated from one year to the next. Moreover, this study did not allow us to specify the number of children with clinical severity criteria on our island.
By carrying out a study over a longer period, the investigators will have a better understanding of seasonality and the rate of disease in children in Martinique, allowing us to better anticipate the extent and severity of these phenomena. This precision will allow us to determine when to start Monoclonal Antibody injections for vulnerable children (essentially infants with chronic respiratory pathologies or congenital cardiac pathologies, i.e. approximately 30 children per year in Martinique). The investigators will also be able to anticipate future needs of beds and caregivers to the epidemic to come or in progress. The investigators will therefore have better preventive care for children at risk and better preparation of the healthcare offer.
Research questions
- Descriptions of the characteristics of RSV bronchiolitis epidemics (seasonality, rate of occurrence, case profile)?
- What are the factors that may explain a specific seasonality and case rate in tropical zones, especially Martinique? What is the role of climatic factors?
Research hypotheses The investigators believe that the seasonality and characteristics of RSV bronchiolitis are indeed specific to tropical areas such as Martinique.
The investigators hypothesize that, in tropical areas, certain favourable climatic conditions, prevailing in the month prior to the usual period of RSV bronchiolitis outbreak onset or during the epidemic, would be intrinsically linked to the characteristics of these epidemics.
Indeed, RSV is a virus that particularly likes humid atmospheres in which to develop. These conditions are conducive during the rainy season in the tropics (second half of the year in Martinique), which could explain a different seasonality from that known in temperate regions (where the epidemic occurs rather during the winter). These favourable climatic conditions can be approximated by measuring the humidity level, the number of rainy days, the average temperature, the rate of sunshine and cloud cover and the average wind strength. In addition, respiratory irritants such as sand mist or other air pollution, as assessed by the air quality index, could be among the parameters that explain these differences.
The investigators propose to retrospectively analyze 12 years of hospital data on RSV bronchiolitis cases in Martinique among hospitalized children 2 years of age and younger, the main targets of RSV, and therefore the population most vulnerable to this virus. The investigators will focus only on hospitalized patients because they are the most severely affected patients, which will allow us to accurately describe the clinical severity criteria in this at-risk population.
Main objective Describe the temporal distribution of RSV bronchiolitis cases in children 2 years of age or younger hospitalized in Martinique, over a 12-year period (2007 to 2018), based on climatic parameters prevailing in the month before the beginning of the epidemic or during the epidemic.
Secondary objectives
- Describe the weekly and monthly distribution of RSV bronchiolitis, over the 12-year study period, among children 2 years of age and younger hospitalized in Martinique.
- Describe the characteristics of each epidemic observed over the study period.
- Describe the characteristics of RSV bronchiolitis cases during the study period.
- Analyze the association between the climatic parameters studied and the occurrence of RSV bronchiolitis.
- Keywords
- Bronchiolitis, Respiratory Syncytial Virus, Child, Infant, premature, Bronchopulmonary Dysplasia, Heart Defects, Congenital, Tropical climate, Humidity, Epidemiology, Air pollution
- Medical subject headings
- Bronchiolitis, Premature Birth, Bronchopulmonary Dysplasia, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : 7-day average humidity (%)
Measured: 1 year
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : number of significant rainy days (j)
Measured: 1 year
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : average temperature (°C) over one day
Measured: Through study completion, an average of 1 year
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : global solar radiation (joules/cm²)
Measured: 1 year
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : average wind force (km/h)
Measured: 1 year
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : concentrations, in µg/m3, of air pollutants (such as nitrogen oxides (NOx) and fine particulate matter (PM10))
Measured: 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: 7-day average humidity (%)
Measured: Through study completion, an average of 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: number of significant rainy days (j)
Measured: 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: average temperature (°C) over one day
Measured: 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: solar radiation (joules/cm²)
Measured: 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: average wind force (km/h)
Measured: 1 year
RSV cases by month compare with climatic factors at the same time
Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).
Measured: 1 year
Secondary outcomes (6)
Distribution of RSV bronchiolitis
Weekly and monthly distribution of RSV bronchiolitis
Measured: 1 year
Distribution of RSV bronchiolitis
Weekly distribution of RSV bronchiolitis
Measured: By week
Distribution of RSV bronchiolitis
Monthly distribution of RSV bronchiolitis
Measured: Through study completion, an average of 1 year
Characteristics of each epidemic
Characteristics of each epidemic (beginning, peak and end of epidemic; number of incident cases per week, month and year; incidence curve per week, month and year; rate of attainment (cumulative incidence of infection over the period))
Measured: 1 year
Characteristics of incident cases
Characteristics of incident cases: sex, age, hospitalization in pediatric ICU, oxygen therapy, assisted respiration rate, enteral nutrition rate, prematurity, chronic respiratory pathology of the former prematurity, congenital heart disease.)
Measured: 1 year
Climatic parameters and RSV bronchiolitis
Correlation between the climatic parameters studied and the occurrence of RSV bronchiolitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start2 Oct 2019
- Primary completion2 Jun 2021
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis; Respiratory Syncytial VirusStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier FLECHELLES, MD, Principal investigator, Hospital University of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415229
- Sponsor's protocol ID
- 19_MR004-11
- Acronym
- VRS-12
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bont L, Checchia PA, Fauroux B, Figueras-Aloy J, Manzoni P, Paes B, Simoes EA, Carbonell-Estrany X. Defining the Epidemiology and Burden of Severe Respiratory Syncytial Virus Infection Among Infants and Children in Western Countries. Infect Dis Ther. 2016 Sep;5(3):271-98. doi: 10.1007/s40121-016-0123-0. Epub 2016 Aug 1.
PubMed 27480325RAMEIX-WELTI M, GAULT E. Le virus respiratoire syncytial (VRS): état actuel des connaissances. Feuill. Biol. 2017;29-41.
Welliver TP, Garofalo RP, Hosakote Y, Hintz KH, Avendano L, Sanchez K, Velozo L, Jafri H, Chavez-Bueno S, Ogra PL, McKinney L, Reed JL, Welliver RC Sr. Severe human lower respiratory tract illness caused by respiratory syncytial virus and influenza virus is characterized by the absence of pulmonary cytotoxic lymphocyte responses. J Infect Dis. 2007 Apr 15;195(8):1126-36. doi: 10.1086/512615. Epub 2007 Mar 9.
PubMed 17357048Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simoes EA, Manzoni P, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Chronic Lung Disease. Infect Dis Ther. 2016 Dec;5(4):453-471. doi: 10.1007/s40121-016-0137-7. Epub 2016 Nov 18.
PubMed 27864751Checchia PA, Paes B, Bont L, Manzoni P, Simoes EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Congenital Heart Disease. Infect Dis Ther. 2017 Mar;6(1):37-56. doi: 10.1007/s40121-016-0142-x. Epub 2017 Jan 9.
PubMed 28070870Sande CJ, Mutunga MN, Medley GF, Cane PA, Nokes DJ. Group- and genotype-specific neutralizing antibody responses against respiratory syncytial virus in infants and young children with severe pneumonia. J Infect Dis. 2013 Feb 1;207(3):489-92. doi: 10.1093/infdis/jis700. Epub 2012 Nov 21.
PubMed 23175761Yamaguchi M, Sano Y, Dapat IC, Saito R, Suzuki Y, Kumaki A, Shobugawa Y, Dapat C, Uchiyama M, Suzuki H. High frequency of repeated infections due to emerging genotypes of human respiratory syncytial viruses among children during eight successive epidemic seasons in Japan. J Clin Microbiol. 2011 Mar;49(3):1034-40. doi: 10.1128/JCM.02132-10. Epub 2010 Dec 22.
PubMed 21177891Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PubMed 20399493Equipe de surveillance de la bronchiolite. Surveillance de la bronchiolite en France, saison 2016-2017. Bull Epidémiol Hebd. 2017;650-657.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonality of Respiratory Syncytial Virus (RSV) Bronchiolitis in Children Aged 2 Years or Less Hospitalized in Martinique (French West Indies) a Tropical Area From 2007 to 2018
- ClinicalTrials.gov ID
- NCT04415229
- Acronym / sponsor ID
- VRS-12 / 19_MR004-11
- Keywords
- Bronchiolitis, Respiratory Syncytial Virus, Child, Infant, premature, Bronchopulmonary Dysplasia, Heart Defects, Congenital, Tropical climate, Humidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 4 Jun 2020 (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.
The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put forward: influence of favorable climatic conditions in the month preceding the start of the epidemic. In addition, the study will improve our knowledge of the epidemiology of the infection in order to improve the management of infants.
Detailed description
Respiratory Syncytial Virus (RSV) infections are the leading cause of hospitalization for respiratory distress in infants (50% of children under 1 year of age are infected with the virus, 100% of children under 3 years of age). They are responsible for 66,000 to 199,000 deaths in children under 5 years of age worldwide, and 15,000 to 20,000 hospitalizations in France depending on the year. It is a highly contagious virus whose transmission is both respiratory and by hand and which appreciates humidity to develop.
In temperate regions where this infection has been well studied, it occurs preferentially during the winter, probably favoured by the cold and humidity, as well as by the confinement of individuals during this season. The more the child is young, premature, has a chronic respiratory pathology or congenital heart disease, the more sever the disease. Prevention is based on the injection of a monoclonal antibody (Palivizumab) before the start of the epidemic season and on conventional hygiene measures. But today, little epidemiological data is available for tropical regions and in Martinique, which makes it impossible to understand why, how and when RSV develops on our island. Some epidemiological studies carried out in tropical regions point to the possibility that the humidity in the air would favour viral development and in fact, these epidemics are more frequently found during the rainy season. The humidity level, the number of rainy days, the rate of sunshine and cloud cover, and finally the importance of the wind, could explain a different seasonality from that known in temperate regions (seasonality being linked to the virus circulation patterns and being defined as the ability to re-emerge at the same period from one year to the next).
Research issues A first study carried out at the University hospital of Martinique over a period of 2 years (from July 1, 2007 to December 31, 2008) has made it possible to specify the epidemiology a little better but the results need to be confirmed. This work seems to show that the epidemic starts earlier than in temperate zones: (late August - early September to late November - early December) versus (November - December to March - April) respectively. The number of cases per epidemic can change significantly (factor 2.5). However, this first study was not long enough to ensure that the seasonality identified will be systematically repeated from one year to the next. Moreover, this study did not allow us to specify the number of children with clinical severity criteria on our island.
By carrying out a study over a longer period, the investigators will have a better understanding of seasonality and the rate of disease in children in Martinique, allowing us to better anticipate the extent and severity of these phenomena. This precision will allow us to determine when to start Monoclonal Antibody injections for vulnerable children (essentially infants with chronic respiratory pathologies or congenital cardiac pathologies, i.e. approximately 30 children per year in Martinique). The investigators will also be able to anticipate future needs of beds and caregivers to the epidemic to come or in progress. The investigators will therefore have better preventive care for children at risk and better preparation of the healthcare offer.
Research questions
- Descriptions of the characteristics of RSV bronchiolitis epidemics (seasonality, rate of occurrence, case profile)?
- What are the factors that may explain a specific seasonality and case rate in tropical zones, especially Martinique? What is the role of climatic factors?
Research hypotheses The investigators believe that the seasonality and characteristics of RSV bronchiolitis are indeed specific to tropical areas such as Martinique.
The investigators hypothesize that, in tropical areas, certain favourable climatic conditions, prevailing in the month prior to the usual period of RSV bronchiolitis outbreak onset or during the epidemic, would be intrinsically linked to the characteristics of these epidemics.
Indeed, RSV is a virus that particularly likes humid atmospheres in which to develop. These conditions are conducive during the rainy season in the tropics (second half of the year in Martinique), which could explain a different seasonality from that known in temperate regions (where the epidemic occurs rather during the winter). These favourable climatic conditions can be approximated by measuring the humidity level, the number of rainy days, the average temperature, the rate of sunshine and cloud cover and the average wind strength. In addition, respiratory irritants such as sand mist or other air pollution, as assessed by the air quality index, could be among the parameters that explain these differences.
The investigators propose to retrospectively analyze 12 years of hospital data on RSV bronchiolitis cases in Martinique among hospitalized children 2 years of age and younger, the main targets of RSV, and therefore the population most vulnerable to this virus. The investigators will focus only on hospitalized patients because they are the most severely affected patients, which will allow us to accurately describe the clinical severity criteria in this at-risk population.
Main objective Describe the temporal distribution of RSV bronchiolitis cases in children 2 years of age or younger hospitalized in Martinique, over a 12-year period (2007 to 2018), based on climatic parameters prevailing in the month before the beginning of the epidemic or during the epidemic.
Secondary objectives
- Describe the weekly and monthly distribution of RSV bronchiolitis, over the 12-year study period, among children 2 years of age and younger hospitalized in Martinique.
- Describe the characteristics of each epidemic observed over the study period.
- Describe the characteristics of RSV bronchiolitis cases during the study period.
- Analyze the association between the climatic parameters studied and the occurrence of RSV bronchiolitis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 2 years of age or younger hospitalized in Martinique with RSV bronchiolitis cases, over a 12-year period (2007 to 2018)
Key inclusion criteria (5 listed)
- two years of age or younger
- hospitalized for bronchiolitis in the pediatrics department of the University hospital of Martinique over the period 2007 to 2018
- with a confirmed virological diagnosis of RSV virus by ImmunoFluorescence (IF) from 01/01/2007 to 31/01/2016 and from 01/02/2016 by Reverse transcription polymerase chain reaction.
- with a clinical diagnosis of bronchiolitis (presentation of suggestive clinical signs such as cough, respiratory distress associated with a febrile illness, with rhinopharyngitis in the previous days)
- no opposition from the legal representative for the use of the data from the medical file in the context of the research. This non-opposition is documented in the patient's medical file
Key exclusion criteria (2 listed)
- opposition from the legal representative for the use of the data from the medical file
- Inability to inform legal representatives of the conduct of the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : 7-day average humidity (%)
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : number of significant rainy days (j)
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: Through study completion, an average of 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : average temperature (°C) over one day
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : global solar radiation (joules/cm²)
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : average wind force (km/h)
Incident cases of RSV bronchiolitis in children between 2007 and 2018
Time frame: 1 year
Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : concentrations, in µg/m3, of air pollutants (such as nitrogen oxides (NOx) and fine particulate matter (PM10))
RSV cases by month compare with climatic factors at the same time
Time frame: Through study completion, an average of 1 year
Climatic parameters: 7-day average humidity (%)
RSV cases by month compare with climatic factors at the same time
Time frame: 1 year
Climatic parameters: number of significant rainy days (j)
RSV cases by month compare with climatic factors at the same time
Time frame: 1 year
Climatic parameters: average temperature (°C) over one day
RSV cases by month compare with climatic factors at the same time
Time frame: 1 year
Climatic parameters: solar radiation (joules/cm²)
RSV cases by month compare with climatic factors at the same time
Time frame: 1 year
Climatic parameters: average wind force (km/h)
RSV cases by month compare with climatic factors at the same time
Time frame: 1 year
Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).
6 secondary outcomes
Distribution of RSV bronchiolitis
Time frame: 1 year
Distribution of RSV bronchiolitis
Time frame: By week
Distribution of RSV bronchiolitis
Time frame: Through study completion, an average of 1 year
Characteristics of each epidemic
Time frame: 1 year
Characteristics of incident cases
Time frame: 1 year
Climatic parameters and RSV bronchiolitis
Time frame: 1 year
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 19 Jul 2023.
- Background: PubMed 27480325Bont L, Checchia PA, Fauroux B, Figueras-Aloy J, Manzoni P, Paes B, Simoes EA, Carbonell-Estrany X. Defining the Epidemiology and Burden of Severe Respiratory Syncytial Virus Infection Among Infants and Children in Western Countries. Infect Dis Ther. 2016 Sep;5(3):271-98. doi: 10.1007/s40121-016-0123-0. Epub 2016 Aug 1.
- BackgroundRAMEIX-WELTI M, GAULT E. Le virus respiratoire syncytial (VRS): état actuel des connaissances. Feuill. Biol. 2017;29-41.
- Background: PubMed 17357048Welliver TP, Garofalo RP, Hosakote Y, Hintz KH, Avendano L, Sanchez K, Velozo L, Jafri H, Chavez-Bueno S, Ogra PL, McKinney L, Reed JL, Welliver RC Sr. Severe human lower respiratory tract illness caused by respiratory syncytial virus and influenza virus is characterized by the absence of pulmonary cytotoxic lymphocyte responses. J Infect Dis. 2007 Apr 15;195(8):1126-36. doi: 10.1086/512615. Epub 2007 Mar 9.
- Background: PubMed 27864751Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simoes EA, Manzoni P, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Chronic Lung Disease. Infect Dis Ther. 2016 Dec;5(4):453-471. doi: 10.1007/s40121-016-0137-7. Epub 2016 Nov 18.
- Background: PubMed 28070870Checchia PA, Paes B, Bont L, Manzoni P, Simoes EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Congenital Heart Disease. Infect Dis Ther. 2017 Mar;6(1):37-56. doi: 10.1007/s40121-016-0142-x. Epub 2017 Jan 9.
- Background: PubMed 23175761Sande CJ, Mutunga MN, Medley GF, Cane PA, Nokes DJ. Group- and genotype-specific neutralizing antibody responses against respiratory syncytial virus in infants and young children with severe pneumonia. J Infect Dis. 2013 Feb 1;207(3):489-92. doi: 10.1093/infdis/jis700. Epub 2012 Nov 21.
- Background: PubMed 21177891Yamaguchi M, Sano Y, Dapat IC, Saito R, Suzuki Y, Kumaki A, Shobugawa Y, Dapat C, Uchiyama M, Suzuki H. High frequency of repeated infections due to emerging genotypes of human respiratory syncytial viruses among children during eight successive epidemic seasons in Japan. J Clin Microbiol. 2011 Mar;49(3):1034-40. doi: 10.1128/JCM.02132-10. Epub 2010 Dec 22.
- Background: PubMed 20399493Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Results publicationEquipe de surveillance de la bronchiolite. Surveillance de la bronchiolite en France, saison 2016-2017. Bull Epidémiol Hebd. 2017;650-657.
- Individual participant dataSharing planned: Undecided
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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.
Olivier FLECHELLES, MD principal investigator
Hospital University of Martinique
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 Bronchiolitis; Respiratory Syncytial Virus, run by University Hospital Center of Martinique at 1 site in Martinique.
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 2 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 19 Jul 2023. 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 Martinique. 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?
Incident cases of RSV bronchiolitis in children between 2007 and 2018 (time frame: 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415229, which also lists 9 linked publications.
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 19 Jul 2023.