Dengue Fever With Warning SignsDENGUE-RUNNCT05607472
Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island
A study testing blood sampling and questionnary of health estate during 18 month in people with Dengue Fever With Warning Signs, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 months and older
- Conditions the study is for
- Dengue Fever With Warning Signs
- What is being tested?
- blood sampling and questionnary of health estate during 18 month
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2022to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dengue Fever With Warning Signs
- Being tested
- blood sampling, questionnary of health estate during 18 month
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood samples for bio collection
questionnary of health estate during 18 monthOther
clinical exam Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation) during 18 months
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: blood sampling; Other: questionnary of health estate during 18 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start30 Mar 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue Fever With Warning SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuella POTHIN, Study director, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607472
- Sponsor's protocol ID
- 2021/CHU/37
- Acronym
- DENGUE-RUN
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island
- ClinicalTrials.gov ID
- NCT05607472
- Acronym / sponsor ID
- DENGUE-RUN / 2021/CHU/37
- Conditions
- Dengue Fever With Warning Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient with Dengue prognostic purpose | Other | Other: blood sampling, Other: questionnary of health estate during 18 monthblood 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) |
Who may qualify
- Ages
- 8 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood samples for bio collection | Other | All patient with Dengue prognostic purpose |
| questionnary of health estate during 18 monthclinical exam Charlson comorbidity classification questionaries : SHERE and EHAD (emotional evaluation), SF-12, EQ-5D-5L, MFIS-5 (Fatigue evaluation) during 18 months | Other | All patient with Dengue prognostic purpose |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuella POTHIN study director
CHU La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling and questionnary of health estate during 18 month in people with Dengue Fever With Warning Signs, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative risk for hospitalization with dengue of any risk factors measured at inclusion ) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.