Hospital - Based Surveillance of Acute Febrile Illness in Western Ghat Region of

项目主任/首席研究员（Govindakarnavar，Arunkumar）：印度西加特地区的AFI监测 摘要： 实验室诊断学的进步极大地提高了对急性呼吸道感染病原学的认识。 发热性疾病（AFI），如发烧超过一周，包括Kyasanur森林病 (KFD)、钩端螺旋体病、立克次体病（如恙虫病）、登革热及西方的莱姆病 印度的Ghat地区。 本研究旨在描述印度急性发热性疾病（AFI）患者的感染原因， 印度西加特地区的分区医院，覆盖卡纳塔克邦、喀拉拉邦和泰米尔纳德邦。研究 将集中在AFI的细菌，立克次体和病毒原因。根据历史患者数量，估计 将招募大约400名患者（即，符合研究案例的定义） 研究第一阶段或第一年的研究中心之间。这项研究计划在以下核心领域展开： 第一年在卡纳塔克邦的希莫加区优化资源，第二年推广到喀拉拉邦 泰米尔纳德邦在第三年。来自喀拉拉邦和泰米尔纳德邦的新增人口将各为200人。所以在最后 第3年，研究的摄入量应为800。 患者和/或父母/监护人将被要求在首次陈述时参加， 由治疗临床医生确定，包括全血细胞计数和血培养的血液特征 以及对于那些患有神经系统综合征的患者，腰椎穿刺在临床上适用于患者管理。 医院实验室常规进行革兰氏染色、葡萄糖/蛋白水平、细胞计数和细菌培养 （在培养基/试剂可用的情况下）通过腰椎穿刺从患者中获得的脑脊液（CSF） 关于AFI本研究将通过使用基于ELISA的血清学试验寻找病原体， 样本进行一系列其他测试，以检测病原体。 在我们的研究中，将对临床样本进行与AFI相关的各种病因检测，例如细菌性 病原体（钩端螺旋体、沙门氏菌、布鲁氏菌、莱姆病疏螺旋体、沙门氏菌）; pneumoniae、流感嗜血杆菌、N.脑膜炎， 志贺氏菌，弯曲杆菌等），立克次氏体群的生物体（恙虫病，斑点热群，埃里希体， 无形体等）和病毒（KFD，登革热，日本脑炎，西尼罗河病毒，基孔肯雅病毒， 蜱传脑炎病毒，克里米亚刚果出血热病毒，流感病毒，呼吸道 合胞病毒、腺病毒、冠状病毒、肠道病毒、腹泻病毒等）聚合酶链 将使用患者血液、CSF、咽拭子和粪便样本的PCR和血清学分析， 确定已知引起急性发热性疾病的其他病原体。还将对临床样本进行检测， 使用基于PCR序列的病原体发现技术的未知病原体。 PHS 398/2590（版本06/09）第1页续格式页

Program Director/Principal Investigator (Govindakarnavar, Arunkumar): AFI Surveillance in Western Ghat Region of India ABSTRACT: Advances in laboratory diagnostics have greatly enhanced understanding of the infectious etiologies of Acute Febrile Illness (AFI) such as fever of more than a week's duration, including that of Kyasanur Forest Disease (KFD), Leptospirosis, Rickettsial disease such as Scrub Typhus, Dengue and Lyme disease in the Western Ghat region of India. This study aims to characterize the infectious causes of Acute Febrile Illness (AFI) among patients in India, in Sub-District Hospitals in Western Ghat region of India covering Karnataka, Kerala and Tamil Nadu. The study will focus on bacterial, rickettsial and viral causes of AFI. Based on historical patient volumes, it is estimated that approximately 400 patients will be enrolled (i.e., fit the study case definition) over the course of one year between the study sites in the first phase or first year of study. This study plans to roll out in the core area of Shimoga District of Karnataka in the first year to optimize on resources and roll it out to Kerala in second year and Tamil Nadu in the third year. The additions from Kerala and Tamil Nadu would be 200 each. So at the end of 3rd year the intake in the study shall be 800. Patients and/or parents/guardians will be asked to participate at the time of initial presentation, after determination by the treating clinician that a Blood profile including Complete Blood Count and Blood Culture as well as for those with neurological syndrome lumbar puncture is clinically indicated for patient management. Hospital laboratories routinely perform Gram stain, glucose/protein levels, cell count, and bacterial culture (where media/reagents are available) on cerebrospinal fluid (CSF) obtained via lumbar puncture from patients with AFI. This study would look for pathogens by using ELISA based serological tests and subject the specimen to a battery of other tests to lead to pathogen detection. In our study, clinical samples will be tested for a variety of etiologies associated with AFI such as, Bacterial pathogens (Leptospira, Salmonella, Brucella, Lyme borrelia, S. pneumoniae, H.influenzae, N. meningitidis, Shigella, Campylobacter etc. ), Rickettsial group of organisms (Scrub typhus, Spotted fever group, Ehrlichia, Anaplasma etc.) and Viruses ( KFD, Dengue, Japanese Encephalitis, West Nile Virus, Chikungunya virus, Tick borne Encephalitis virus, Crimean Congo Hemorrhagic Fever virus, Influenza viruses, Respiratory Syncytial Virus, Adenovirus, Coronaviruses, Enteroviruses, Diarrhoeagenic viruses etc.) Polymerase chain reaction (PCR) and serologic analyses of patient blood, CSF, Throat swab and Stool samples will be used to identify additional pathogens known to cause Acute febrile illness. Clinical samples also will be tested for unknown pathogens using PCR- sequence based pathogen discovery techniques. PHS 398/2590 (Rev. 06/09) Page 1 Continuation Format Page