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

October 10, 2016 updated by: Thomas Jaenisch, University of Heidelberg Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Febrile patients presenting to outpatient clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Febrile Patients
Observation of patients with possible dengue fever in the early phase of disease
Other: Observation
Clinical follow-up and laboratory investigations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of severe disease
Time Frame: 14 days
Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Heidelberg Medical Center

Collaborators

University of Oxford
European Union

Investigators

  • Principal Investigator: Thomas Jänisch, Heidelberg University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281803 (EU FP7-HEALTH-2011)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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