METHODS: Global Infectious Diseases Network investigators comprising institutions in Colombia, Dominican Republic, México, Perú and the USA, developed a common cohort study protocol. The primary objective is to determine the aetiologies of AUFI at healthcare facilities in high-risk areas. Data collection and laboratory testing for viral, bacterial and parasitic agents are performed in rural and urban healthcare facilities and partner laboratories. Centralised laboratory and data management cores deploy diagnostic tests and data management tools. Subjects >6 years with fever for <8 days without localised infection are included in the cohort. They are evaluated during the acute and convalescent phases of illness. Study personnel collect clinical and epidemiological information. Blood, urine, nasal or pharyngeal swabs and saliva are collected in the acute phase and blood in convalescent phase. Specimens are banked at -80°C. Malaria, dengue and COVID-19 are tested onsite in the acute phase. The acute-phase serum is PCR tested for dengue, chikungunya, Venezuelan equine encephalitis, Mayaro, Oropouche, Zika, and yellow fever viruses. Paired convalescent and acute serum antibody titters are tested for arbovirus, Leptospira spp, and Rickettsia spp. Serum is used for viral cultures and next-generation sequencing for pathogen discovery. Analysis includes variable distributions, risk factors and regression models. Laboratory results are shared with health authorities and network members.
BACKGROUND: The protocol was approved by local ethics committees and health authorities. The results will be published in peer-reviewed journals. All study results are shared with local and regional health authorities.
方法:由哥伦比亚机构组成的全球传染病网络调查人员,多米尼加共和国,墨西哥,秘鲁和美国,制定了通用队列研究方案。主要目标是确定高风险地区医疗机构中AUFI的病因。病毒的数据收集和实验室检测,细菌和寄生虫剂在农村和城市医疗机构和合作伙伴实验室进行。集中式实验室和数据管理核心部署诊断测试和数据管理工具。在队列中包括具有<8天的发热>6年而没有局部感染的受试者。在疾病的急性和恢复期进行评估。研究人员收集临床和流行病学信息。血,尿液,在急性期收集鼻或咽拭子和唾液,在恢复期收集血液。样本在-80°C下存放。疟疾,登革热和COVID-19在急性期进行了现场检测。急性期血清进行登革热PCR检测,基孔肯雅,委内瑞拉马脑炎,Mayaro,Oropouche,Zika,和黄热病病毒。对恢复期和急性血清抗体滴度进行虫媒病毒检测,钩端螺旋体,和立克次体。血清用于病毒培养和用于病原体发现的下一代测序。分析包括变量分布,风险因素和回归模型。实验室结果与卫生当局和网络成员共享。
背景:该方案得到了当地伦理委员会和卫生当局的批准。结果将发表在同行评审的期刊上。所有研究结果均与当地和地区卫生当局共享。