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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Heidelberg Medical Center
Sponsor:
Collaborators:
European Union
University of Oxford
Information provided by (Responsible Party):
Thomas Jaenisch, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier:
NCT01550016
First received: March 7, 2012
Last updated: August 3, 2012
Last verified: August 2012

March 7, 2012
August 3, 2012
October 2011
October 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01550016 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
International Research Consortium on Dengue Risk Assessment, Management, and Surveillance
Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Febrile patients presenting to outpatient clinic

Dengue Fever
Other: Observation
Clinical follow-up and laboratory investigations.
Febrile Patients
Patients with possible dengue fever in the early phase of disease
Intervention: Other: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
5 Years and older
No
Contact: Thomas Jänisch thomas.jaenisch@urz.uni-heidelberg.de
Brazil,   Cambodia,   El Salvador,   Indonesia,   Malaysia,   Vietnam
 
NCT01550016
281803 (EU FP7-HEALTH-2011)
No
Thomas Jaenisch, University of Heidelberg Medical Center
University of Heidelberg Medical Center
  • European Union
  • University of Oxford
Not Provided
University of Heidelberg Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP