登革热的临床评估及重症疾病危险因素的识别：8国多中心研究方案
Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries.
作者信息
Jaenisch Thomas, Tam Dong Thi Hoai, Kieu Nguyen Tan Thanh, Van Ngoc Tran, Nam Nguyen Tran, Van Kinh Nguyen, Yacoub Sophie, Chanpheaktra Ngoun, Kumar Varun, See Lucy Lum Chai, Sathar Jameela, Sandoval Ernesto Pleités, Alfaro Gabriela Maria Marón, Laksono Ida Safitri, Mahendradhata Yodi, Sarker Malabika, Ahmed Firoz, Caprara Andrea, Benevides Bruno Souza, Marques Ernesto T A, Magalhaes Tereza, Brasil Patricia, Netto Marco, Tami Adriana, Bethencourt Sarah E, Guzman Maria, Simmons Cameron, Quyen Nguyen Thanh Ha, Merson Laura, Dung Nguyen Thi Phuong, Beck Dorothea, Wirths Marius, Wolbers Marcel, Lam Phung Khanh, Rosenberger Kerstin, Wills Bridget
机构信息
Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, District 5, Ho Chi Minh City, Vietnam.
出版信息
BMC Infect Dis. 2016 Mar 11;16:120. doi: 10.1186/s12879-016-1440-3.
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.
背景
登革热的全球负担持续增加，估计每年有1亿例出现临床症状的感染病例。虽然大多数登革热感染是无症状的，但患者可能会出现广泛的临床症状，从轻度发热疾病到因系统性血管渗漏综合征导致的出血、器官损害和低血容量性休克等严重表现。登革热的临床诊断以及确定哪些患者可能发展为严重疾病仍然具有挑战性。本研究旨在通过以下方法改善诊断和临床管理：a）在发热开始72小时内区分登革热和其他常见发热疾病；b）在登革热患者中识别可预测发展为更严重病程可能性的标志物。
方法/设计：这是一项前瞻性多中心观察性研究，旨在招募7000 - 8000名年龄≥5岁、出现与登革热相符的发热疾病的参与者，这些参与者分布在亚洲和拉丁美洲8个国家的门诊医疗机构。发热开始72小时内就诊且未表现出严重疾病迹象的患者符合研究条件。在急性疾病期间，每天评估一系列广泛的临床和实验室参数，持续长达6天，1周后进行随访时也进行评估。
讨论
来自这一大群早期因未分化发热而入选的患者的数据，将用于制定实用的诊断算法和可靠的登革热临床病例定义。此外，在确诊登革热的患者中，我们旨在识别与发展为更严重病程相关的简单临床和实验室参数。我们还将研究严重疾病的早期病毒学和血清学关联，并在这个大型异质性队列中检查基因关联。此外，研究结果将用于评估世界卫生组织新的登革热分类方案在实际中的应用，并更新登革热流行国家使用的“儿童疾病综合管理”指南。
试验注册
NCT01550016。注册日期：2012年3月7日。
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