International Research Consortium on Dengue Risk Assessment, Management, and Surveillance (IDAMS)

University of Heidelberg Medical Center

Status: Completed

Conditions: Dengue Fever

Treatments: Other: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT01550016

281803 (EU FP7-HEALTH-2011)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,411 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7,411 participants in 1 patient group

Febrile Patients

Description:

Observation of patients with possible dengue fever in the early phase of disease

Treatment:

Other: Observation