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

NCT05607472 | Active Not Recruiting

• 1 other identifier: 2021/CHU/37
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue Fever With Warning Signs

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (1)

All patient with Dengue prognostic purpose

OTHER

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; Other: questionnary of health estate during 18 month

Interventions

blood sampling OTHER

blood samples for bio collection

All patient with Dengue prognostic purpose

questionnary of health estate during 18 month OTHER

clinical exam Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation) during 18 months

All patient with Dengue prognostic purpose

Eligibility Criteria

• Age: 8 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Patrick GERARDIN

Saint-Pierre, 97410, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Manuella POTHIN

  CHU La Réunion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: November 7, 2022
• Study Start: March 30, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

FR (1)