Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island (DENGUE-RUN)

October 24, 2023 updated by: Centre Hospitalier Universitaire de la Réunion

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Pierre, France, 97410
        • Patrick GERARDIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

  • Study Director: Manuella POTHIN, CHU La Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/CHU/37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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