NCT01550016

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,411 (actual)
• Sponsor: University of Heidelberg Medical Center · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
OTHER	Observation	Clinical follow-up and laboratory investigations.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-06-01
• Completion: 2016-10-01
• First posted: 2012-03-09
• Last updated: 2016-10-11

Locations

9 sites across 8 countries: Bangladesh, Brazil, Cambodia, El Salvador, Indonesia, Malaysia, Venezuela, Vietnam