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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients (including pregnant women) or children (> 8 kg)

  • Admitted to the Emergency Department, in the hospital wards, or in outpatient clinics from the two teaching hospitals of Réunion island
  • with a definite or probable diagnosis of dengue, as defined by a positive PCR (plasma or urine), NS1 antigen within the first five days of onset of symptoms; or 2 serologies indicating a recent primary or a secondary infection (positive IgM twice or IgG seroconversion x 4 at a minimum of 10 days apart)
  • affiliated to a social insurance

Exclusion Criteria:

  • refusal of participation as expressed by the patient or its entourage (if the patient is physically unable to give his opinion)
  • absence of social insurance
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Patrick GERARDIN, Dr +262 (0) 2 62 35 90 00 ext + 5 93 4 patrick.gerardin@chu-reunion.fr
Contact: Mélanie BEGORRE 02 62 71 78 85 melanie.begorre@chu-reunion.fr

Locations
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France
Patrick GERARDIN Recruiting
Saint-Pierre, France, 97410
Contact: Patrick GERARDIN    02 62 35 90 00 ext 5 93 45    patrick.gerardin@chu-reunion.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Study Director: Manuella POTHIN CHU La Réunion
More Information
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT05607472    
Other Study ID Numbers: 2021/CHU/37
First Posted: November 7, 2022    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral