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
  Purpose

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.


Estimated Enrollment: 10000
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Febrile Patients
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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Febrile patients presenting to outpatient clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550016

Contacts
Contact: Thomas Jänisch thomas.jaenisch@urz.uni-heidelberg.de

Locations
Brazil
Fundacao Universidade Estadual do Ceara Recruiting
Fortaleza, Brazil
Contact: Andrea Caprara       andreacaprara1@gmail.com   
Cambodia
Angkor Hospital for Children Recruiting
Siem Reap, Cambodia
Contact: Varun Kumar       varun@angkorhospital.org   
Contact: William Housworth         
El Salvador
Hospital National de Ninos Benjamin Bloom Recruiting
San Salvador, El Salvador
Contact: Gabriela Maron       gabrielamaron@yahoo.com   
Contact: Ernesto Pleites         
Indonesia
Gadjah Madah University Recruiting
Yogyakarta, Indonesia
Contact: Ida Safitri-Laksono         
Contact       ida_laksono@hotmail.com   
Malaysia
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Lucy Lum       lumcs@ummc.edu.my   
Vietnam
Oxford University Clinical Research Unit Recruiting
Ho Chi Minh City, Vietnam
Contact: Bridget Wills       bwills@oucru.org   
Sponsors and Collaborators
University of Heidelberg Medical Center
European Union
University of Oxford
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jaenisch, Principal Investigator, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT01550016     History of Changes
Other Study ID Numbers: 281803 (EU FP7-HEALTH-2011)
Study First Received: March 7, 2012
Last Updated: August 3, 2012
Health Authority: Germany: Ethics Commission

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:
Dengue
Arbovirus Infections
Flaviviridae Infections
Flavivirus Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014