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

Dengue Fever Clinical Trial

— IDAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550016
• Other study ID #: 281803 (EU FP7-HEALTH-2011)
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: October 10, 2016
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Heidelberg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7411
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Other:
• Observation
Clinical follow-up and laboratory investigations.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Diseases	Dhaka
Brazil	Fundacao Universidade Estadual do Ceara	Fortaleza
Brazil	Fundacao Oswaldo Cruz (FIOCRUZ)	Rio de Janeiro
Cambodia	Angkor Hospital for Children	Siem Reap
El Salvador	Hospital National de Ninos Benjamin Bloom	San Salvador
Indonesia	Gadjah Madah University	Yogyakarta
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Venezuela	Universidad de Carabobo	Valencia
Vietnam	Oxford University Clinical Research Unit	Ho Chi Minh City

Sponsors (3)

Lead Sponsor	Collaborator
University of Heidelberg Medical Center	European Union, University of Oxford

Countries where clinical trial is conducted

Bangladesh,  Brazil,  Cambodia,  El Salvador,  Indonesia,  Malaysia,  Venezuela,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization or administration of IV fluid	Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.	14 days	No
Secondary	Development of severe disease	Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.	14 days	No

External Links

•   IDAMS consortium
•   Oxford University Clinical Research Unit, Viet Nam
•   Section Clinical Tropical Medicine, Heidelberg University Medical Center, Germany