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

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ClinicalTrials.gov Identifier: NCT01550016

Recruitment Status : Completed

First Posted : March 9, 2012

Last Update Posted : October 11, 2016

Sponsor:

Collaborators:

European Union

University of Oxford

Information provided by (Responsible Party):

Thomas Jaenisch, University of Heidelberg Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Dengue Fever	Other: Observation

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 Design

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Study Type :	Observational
Actual Enrollment :	7411 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Clinical Evaluation of Dengue and Identification of Risk Factors for Severe Disease (WP1)
Study Start Date :	October 2011
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Genetic and Rare Diseases Information Center resources: Dengue Fever Viral Hemorrhagic Fever

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Development of severe disease [ Time Frame: 14 days ]
Development of severe disease according to the 2009 WHO Dengue classification within 14 days of enrollment.

Biospecimen Retention: Samples With DNA

Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	5 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550016

Locations

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

Sponsors and Collaborators

University of Heidelberg Medical Center

European Union

University of Oxford

Investigators

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Principal Investigator:	Thomas Jänisch	Heidelberg University Medical Center

More Information

Additional Information:

IDAMS consortium This link exits the ClinicalTrials.gov site

Section Clinical Tropical Medicine, Heidelberg University Medical Center, Germany This link exits the ClinicalTrials.gov site

Oxford University Clinical Research Unit, Viet Nam This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jaenisch T, Tam DT, Kieu NT, Van Ngoc T, Nam NT, Van Kinh N, Yacoub S, Chanpheaktra N, Kumar V, See LL, Sathar J, Sandoval EP, Alfaro GM, Laksono IS, Mahendradhata Y, Sarker M, Ahmed F, Caprara A, Benevides BS, Marques ET, Magalhaes T, Brasil P, Netto M, Tami A, Bethencourt SE, Guzman M, Simmons C, Quyen NT, Merson L, Dung NT, Beck D, Wirths M, Wolbers M, Lam PK, Rosenberger K, Wills B. Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries. BMC Infect Dis. 2016 Mar 11;16:120. doi: 10.1186/s12879-016-1440-3.

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Responsible Party:	Thomas Jaenisch, Principal Investigator, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier:	NCT01550016
Other Study ID Numbers:	281803 (EU FP7-HEALTH-2011)
First Posted:	March 9, 2012 Key Record Dates
Last Update Posted:	October 11, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Thomas Jaenisch, University of Heidelberg Medical Center:


dengue warning signs latin america south east asia other febrile illnesses dengue classification

Additional relevant MeSH terms:

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

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