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OpenTrials
Completed

NCT Number: NCT01550016

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

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.

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Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

International Centre for Diarrhoeal Diseases, Dhaka, Dhaka Division, Bangladesh

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Clinical follow-up and laboratory investigations.

Primary outcomes

  1. Hospitalization or administration of IV fluid

    Time frame: 14 days

    Proportion of dengue patients hospitalized or treated with IV fluids within 14 days of enrollment.

Secondary outcomes

  1. Development of severe disease

    Time frame: 14 days

    Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.

Sponsors and collaborators

Lead sponsor

University of Heidelberg Medical Center

Other

Collaborators

  • European Union
  • University of Oxford

Registry information

Official study title

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

Acronym: IDAMS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2012
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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