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

This study has been completed.
European Union
University of Oxford
Information provided by (Responsible Party):
Thomas Jaenisch, University of Heidelberg Medical Center Identifier:
First received: March 7, 2012
Last updated: October 10, 2016
Last verified: October 2016
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.

Condition Intervention
Dengue Fever
Other: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)

Resource links provided by NLM:

Further study details as provided by University of Heidelberg Medical Center:

Primary Outcome Measures:
  • Hospitalization or administration of IV fluid [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.

Secondary Outcome Measures:
  • Development of severe disease [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.

Biospecimen Retention:   Samples With DNA
Blood samples

Enrollment: 7411
Study Start Date: October 2011
Study Completion Date: October 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Febrile Patients
Observation of patients with possible dengue fever in the early phase of disease
Other: Observation
Clinical follow-up and laboratory investigations.

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.

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Febrile patients presenting to outpatient clinic

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01550016

International Centre for Diarrhoeal Diseases
Dhaka, Bangladesh, 1212
Fundacao Universidade Estadual do Ceara
Fortaleza, Brazil
Fundacao Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro, Brazil
Angkor Hospital for Children
Siem Reap, Cambodia
El Salvador
Hospital National de Ninos Benjamin Bloom
San Salvador, El Salvador
Gadjah Madah University
Yogyakarta, Indonesia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Universidad de Carabobo
Valencia, Venezuela
Oxford University Clinical Research Unit
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
University of Heidelberg Medical Center
European Union
University of Oxford
Principal Investigator: Thomas Jänisch Heidelberg University Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Jaenisch, Principal Investigator, University of Heidelberg Medical Center Identifier: NCT01550016     History of Changes
Other Study ID Numbers: 281803 (EU FP7-HEALTH-2011) 
Study First Received: March 7, 2012
Last Updated: October 10, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Heidelberg Medical Center:
dengue warning signs
latin america
south east asia
other febrile illnesses
dengue classification

Additional relevant MeSH terms:
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral processed this record on October 21, 2016