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

Autor: Jaenisch T; Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Tam DT; 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., Kieu NT; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam., Van Ngoc T; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Nam NT; Children's Hospital Number 2, Ho Chi Minh City, Vietnam., Van Kinh N; National Hospital for Tropical Diseases, Hanoi, Vietnam., Yacoub S; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam.; Department of Medicine, Imperial College, London, UK., Chanpheaktra N; Angkor Hospital for Children, Siem Reap, Cambodia., Kumar V; Angkor Hospital for Children, Siem Reap, Cambodia.; Present address: Rwanda Military Hospital and the University of Rwanda in Kigali, Kigali, Rwanda., See LL; University of Malaya Medical Centre, Kuala Lumpur, Malaysia., Sathar J; Ampang Hospital, Kuala Lumpur, Malaysia., Sandoval EP; Hospital Nacional de Niños Benjamin Bloom, San Salvador, El Salvador., Alfaro GM; Hospital Nacional de Niños Benjamin Bloom, San Salvador, El Salvador.; Present address: St. Jude Children's Research Hospital, Memphis, TN, USA., Laksono IS; Gadjah Mada University, Yogyakarta, Indonesia., Mahendradhata Y; Gadjah Mada University, Yogyakarta, Indonesia., Sarker M; James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh., Ahmed F; International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh., Caprara A; Universidade Estadual Do Ceará, Fortaleza, Brazil., Benevides BS; Universidade Estadual Do Ceará, Fortaleza, Brazil., Marques ET; Centro de Pesquisas Aggeu Magalhaes, Fundacao Oswaldo Cruz, Recife, Pernambuco, Brazil., Magalhaes T; Centro de Pesquisas Aggeu Magalhaes, Fundacao Oswaldo Cruz, Recife, Pernambuco, Brazil., Brasil P; Instituto Nacional de Infectologia Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil., Netto M; Secretaria Municipal de Saúde de Resende, Rio de Janeiro, Brazil., Tami A; 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., Bethencourt SE; Facultad de Ciencias de la Salud, Universidad de Carabobo, Valencia, Venezuela., Guzman M; Institute Pedro Kouri, Havana, Cuba., Simmons C; 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., Quyen NT; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam., Merson L; 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., Dung NT; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam., Beck D; Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Wirths M; Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Wolbers M; 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., Lam PK; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam., Rosenberger K; Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Wills B; Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam. bwills@oucru.org.; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, Oxford University, Oxford, UK. bwills@oucru.org.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2016 Mar 11; Vol. 16, pp. 120. Date of Electronic Publication: 2016 Mar 11.
DOI: 10.1186/s12879-016-1440-3
Abstrakt: 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.
Databáze: MEDLINE