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

NCT ID: NCT01550016

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dengue Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Febrile Patients

Observation of patients with possible dengue fever in the early phase of disease

Observation

Intervention Type OTHER

Clinical follow-up and laboratory investigations.

Interventions

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Observation

Clinical follow-up and laboratory investigations.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Union

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Heidelberg Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Thomas Jaenisch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Jänisch

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Medical Center

Locations

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International Centre for Diarrhoeal Diseases

Dhaka, Dhaka Division, Bangladesh

Site Status

Fundacao Oswaldo Cruz (FIOCRUZ)

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Fundacao Universidade Estadual do Ceara

Fortaleza, , Brazil

Site Status

Angkor Hospital for Children

Siem Reap, , Cambodia

Site Status

Hospital National de Ninos Benjamin Bloom

San Salvador, , El Salvador

Site Status

Gadjah Madah University

Yogyakarta, , Indonesia

Site Status

University of Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Universidad de Carabobo

Valencia, Valencia, Venezuela

Site Status

Oxford University Clinical Research Unit

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Bangladesh Brazil Cambodia El Salvador Indonesia Malaysia Venezuela Vietnam

References

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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.

Reference Type DERIVED
PMID: 26968374 (View on PubMed)

Related Links

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http://www.idams.eu

IDAMS consortium

http://www.klinikum.uni-heidelberg.de/Sektion-Klinische-Tropenmedizin.5489.0.html

Section Clinical Tropical Medicine, Heidelberg University Medical Center, Germany

http://www.oucru.org

Oxford University Clinical Research Unit, Viet Nam

Other Identifiers

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281803 (EU FP7-HEALTH-2011)

Identifier Type: -

Identifier Source: org_study_id

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