International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

Study Overview
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Brief Summary
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Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.

Detailed Description
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Improvements in clinical diagnosis of dengue and risk prediction for severe disease are urgently needed to improve overall clinical care, especially in settings with a high case burden where appropriate allocation of limited resources is crucial to outcome. In this work package 10,000 outpatients with undifferentiated fever, consistent with possible dengue, will be recruited within 3 days of fever onset in 6 endemic countries (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam), and will be followed daily until full recovery. Clinical features and simple laboratory parameters differentiating dengue from other febrile illness will be identified, and, among those with confirmed dengue, risk factors for progression to more severe disease will be evaluated. As well as contributing to the development of diagnostic and prognostic algorithms the clinical cohort has considerable potential towards standardisation of procedures for dengue management and reporting.

Official Title
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Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)

Conditions
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Dengue Fever

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 5 years of age fever for less than 72 hours Exclusion Criteria: presence of localizing signs suggestive of another diagnosis not likely to come back for daily follow-up complications or signs of severe disease

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Febrile Patients<br>Observation of patients with possible dengue fever in the early phase of disease | Other: Observation<br>* Clinical follow-up and laboratory investigations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization or administration of IV fluid | Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of severe disease | Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dengue warning signs, latin america, south east asia, other febrile illnesses, dengue classification