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

Primary Purpose

Dengue Fever With Warning Signs

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
questionnary of health estate during 18 month
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dengue Fever With Warning Signs

Eligibility Criteria

8 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Patrick GERARDIN

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patient with Dengue prognostic purpose

Arm Description

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)

Outcomes

Primary Outcome Measures

The relative risk for hospitalization with dengue of any risk factors measured at inclusion )
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2022
Last Updated
October 24, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT05607472
Brief Title
Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island
Acronym
DENGUE-RUN
Official Title
Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever With Warning Signs

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patient with Dengue prognostic purpose
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
blood sampling
Intervention Description
blood samples for bio collection
Intervention Type
Other
Intervention Name(s)
questionnary of health estate during 18 month
Intervention Description
clinical exam Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation) during 18 months
Primary Outcome Measure Information:
Title
The relative risk for hospitalization with dengue of any risk factors measured at inclusion )
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuella POTHIN
Organizational Affiliation
CHU La Réunion
Official's Role
Study Director
Facility Information:
Facility Name
Patrick GERARDIN
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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