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BMC Infect Dis. 2016 Mar 11;16:120. doi: 10.1186/s12879-016-1440-3.

Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries.

Author information

1
Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
2
Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam.
3
University of Medicine and Pharmacy of Ho Chi Minh City, Ho Chi Minh City, Vietnam.
4
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
5
Children's Hospital Number 2, Ho Chi Minh City, Vietnam.
6
National Hospital for Tropical Diseases, Hanoi, Vietnam.
7
Department of Medicine, Imperial College, London, UK.
8
Angkor Hospital for Children, Siem Reap, Cambodia.
9
Present address: Rwanda Military Hospital and the University of Rwanda in Kigali, Kigali, Rwanda.
10
University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
11
Ampang Hospital, Kuala Lumpur, Malaysia.
12
Hospital Nacional de Niños Benjamin Bloom, San Salvador, El Salvador.
13
Present address: St. Jude Children's Research Hospital, Memphis, TN, USA.
14
Gadjah Mada University, Yogyakarta, Indonesia.
15
James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.
16
International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.
17
Universidade Estadual Do Ceará, Fortaleza, Brazil.
18
Centro de Pesquisas Aggeu Magalhaes, Fundacao Oswaldo Cruz, Recife, Pernambuco, Brazil.
19
Instituto Nacional de Infectologia Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil.
20
Secretaria Municipal de Saúde de Resende, Rio de Janeiro, Brazil.
21
Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
22
Facultad de Ciencias de la Salud, Universidad de Carabobo, Valencia, Venezuela.
23
Institute Pedro Kouri, Havana, Cuba.
24
Department of Microbiology and Immunology, The Peter Doherty Institute, University of Melbourne, Melbourne, Australia.
25
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, Oxford University, Oxford, UK.
26
Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam. bwills@oucru.org.
27
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, Oxford University, Oxford, UK. bwills@oucru.org.

Abstract

BACKGROUND:

The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year. Although most dengue infections are asymptomatic, patients can present with a wide spectrum of clinical symptoms ranging from mild febrile illness through to severe manifestations of bleeding, organ impairment, and hypovolaemic shock due to a systemic vascular leak syndrome. Clinical diagnosis of dengue and identification of which patients are likely to develop severe disease remain challenging. This study aims to improve diagnosis and clinical management through approaches designed a) to differentiate between dengue and other common febrile illness within 72 h of fever onset, and b) among patients with dengue to identify markers that are predictive of the likelihood of evolving to a more severe disease course.

METHOD/DESIGN:

This is a prospective multi-centre observational study aiming to enrol 7-8000 participants aged ≥ 5 years presenting with a febrile illness consistent with dengue to outpatient health facilities in 8 countries across Asia and Latin America. Patients presenting within 72 h of fever onset who do not exhibit signs of severe disease are eligible for the study. A broad range of clinical and laboratory parameters are assessed daily for up to 6 days during the acute illness, and also at a follow up visit 1 week later.

DISCUSSION:

Data from this large cohort of patients, enrolled early with undifferentiated fever, will be used to develop a practical diagnostic algorithm and a robust clinical case definition for dengue. Additionally, among patients with confirmed dengue we aim to identify simple clinical and laboratory parameters associated with progression to a more severe disease course. We will also investigate early virological and serological correlates of severe disease, and examine genetic associations in this large heterogeneous cohort. In addition the results will be used to assess the new World Health Organization classification scheme for dengue in practice, and to update the guidelines for "Integrated Management of Childhood Illness" used in dengue-endemic countries.

TRIAL REGISTRATION:

NCT01550016. Registration Date: March 7, 2012.

KEYWORDS:

Asia; Dengue; Diagnosis; Latin America; Pathogenesis; Risk prediction

PMID:
26968374
PMCID:
PMC4788847
DOI:
10.1186/s12879-016-1440-3
[Indexed for MEDLINE]
Free PMC Article

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