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

BMC Infectious Diseases

Study Protocol

Jameela Sathar¹  Ngoun Chanpheaktra²  Varun Kumar³  Ernesto T. A. Marques⁴  Tereza Magalhaes⁴  Nguyen Tran Nam⁵  Adriana Tami⁶  Sarah E. Bethencourt⁷  Ida Safitri Laksono⁸  Yodi Mahendradhata⁸  Ernesto Pleités Sandoval⁹  Gabriela Maria Marón Alfaro^1,10  Tran Van Ngoc^1,11  Maria Guzman^1,12  Patricia Brasil^1,13  Firoz Ahmed^1,14  Malabika Sarker^1,15  Nguyen Van Kinh^1,16  Nguyen Tan Thanh Kieu^1,17  Phung Khanh Lam^1,17  Nguyen Thi Phuong Dung^1,17  Nguyen Thanh Ha Quyen^1,17  Marcel Wolbers^1,18  Bridget Wills^1,18  Laura Merson^1,18  Sophie Yacoub^1,19  Cameron Simmons^2,20  Dong Thi Hoai Tam^2,21  Marco Netto^2,22  Kerstin Rosenberger^2,23  Thomas Jaenisch^2,23  Marius Wirths^2,23  Dorothea Beck^2,23  Bruno Souza Benevides^2,24  Andrea Caprara^2,24  Lucy Lum Chai See^2,25 

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

关键词: Dengue;    Asia;    Latin America;    Diagnosis;    Risk prediction;    Pathogenesis;   

DOI  :  10.1186/s12879-016-1440-3

 received in 2016-02-02, accepted in 2016-02-18,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignThis 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.DiscussionData 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 registrationNCT01550016. Registration Date: March 7, 2012

【 授权许可】

CC BY   
© Jaenisch et al. 2016