Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dengue Fever
- Sponsor
- University of Heidelberg Medical Center
- Enrollment
- 7411
- Locations
- 9
- Primary Endpoint
- Hospitalization or administration of IV fluid
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Thomas Jaenisch
Principal Investigator
University of Heidelberg Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hospitalization or administration of IV fluid
Time Frame: 14 days
Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.
Secondary Outcomes
- Development of severe disease(14 days)