Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island (DENGUE-RUN)
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|ClinicalTrials.gov Identifier: NCT05607472|
Recruitment Status : Recruiting
First Posted : November 7, 2022
Last Update Posted : November 7, 2022
In recent years, dengue has become endemic on La Réunion island, which has led to subsequent increase of secondary dengue infections, higher severity and higher mortality of the cases referred to the hospital.
This project will investigate the factors associated with the hospitalization for dengue and the factors associated with dengue severity in a hospital-based cohort study conducted over two dengue seasons, as well as the long-term outcomes over aN18-month follow-up.
|Condition or disease||Intervention/treatment||Phase|
|Dengue Fever With Warning Signs||Other: blood sampling Other: questionnary of health estate during 18 month||Not Applicable|
Dengue is a re-emerging infectious disease caused by the four serotypes of dengue virus, a flavivirus transmitted through the bite of a female Aedes mosquito. Dengue heterotypic cross-immunity (against the four serotypes) is short-lived while dengue homotypic immunity (against one serotype) is supposed to be lifelong allowing the possibility of four dengue episodes in a lifetime. In recent years, dengue has become endemic on Réunion island, which has led to the circulation of multiple serotypes (DEN2 in 2018-2019 and DEN1 in 2020-2021), subsequent increase of secondary dengue infections, higher severity and higher mortality of cases referred to the hospital. This project will investigate both the factors associated with the hospitalization for dengue and the factors associated with dengue severity in a hospital-based cohort study conducted over two dengue seasons, as well as the long-term outcomes over an 18-month follow-up. The investigators hypothesize that in an epidemiological context of endemization (which means in the transition from sporadicity towards endemicity), primary dengue infections will be still prominent and severe dengue will be associated with comorbidities rather to prior infections occurring in healthy backgrounds. The data collection will consist in clinical, biological and survey data. Electronic case report forms will be informed by medical doctors and research assistants in outpatient clinics, emergency departments, intensive care units and short-stay admission units. A biobank will be set up on this occasion including serum, plasma, PBMC, DNA, RNA urine samples and possibly CSF.
The follow-up will screen post-infectious long-term manifestations such as chronic fatigue syndrome, musculoskeletal disorders, anxiodepressive or cognitive disorders, and sequelae 3 months, 6 months 12 months and 18 months after the dengue event.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island|
|Actual Study Start Date :||March 3, 2022|
|Estimated Primary Completion Date :||October 1, 2023|
|Estimated Study Completion Date :||October 1, 2023|
All patient with Dengue prognostic purpose
blood samples for bio collection clinical exam : Fitzpatrick phototype classification , Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation)
Other: blood sampling
blood samples for bio collection
Other: questionnary of health estate during 18 month
clinical exam Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation) during 18 months
- The relative risk for hospitalization with dengue of any risk factors measured at inclusion ) [ Time Frame: 18 months ]The incidence rate ratio (relative risk) for hospitalization with dengue of any risk factors measured at inclusion (first consultation) as identified from a multivariate Poisson regression model for dichotomous outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05607472
|Contact: Patrick GERARDIN, Dr||+262 (0) 2 62 35 90 00 ext + 5 93 firstname.lastname@example.org|
|Contact: Mélanie BEGORRE||02 62 71 78 email@example.com|
|Saint-Pierre, France, 97410|
|Contact: Patrick GERARDIN 02 62 35 90 00 ext 5 93 45 firstname.lastname@example.org|
|Study Director:||Manuella POTHIN||CHU La Réunion|