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

项目主任/首席调查员(阿伦库马尔戈文达卡纳瓦尔)：印度西部加特地区的AFI监测 摘要： 实验室诊断学的进步极大地提高了对急性细小病毒感染病因的理解 发热性疾病(AFI)，如持续一周以上的发烧，包括凯萨努尔森林病 西区的斑疹伤寒、登革热和莱姆病等立克次体病、钩端螺旋体病 印度的加特地区。 这项研究旨在描述印度患者中急性发热病(AFI)的感染原因 印度西部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。这项研究 将重点关注AFI的细菌、立克次体和病毒原因。根据历史病人数量，估计 在一年的时间里，将有大约400名患者入选(即符合研究病例定义) 在学习的第一阶段或第一年的学习地点之间。这项研究计划在以下核心地区展开 卡纳塔克邦Shimoga区第一年优化资源，第二年推广到喀拉拉邦 泰米尔纳德邦在第三年。喀拉拉邦和泰米尔纳德邦的新增人数将分别为200人。所以在最后 学习第三年的学生人数为800人。 患者和/或父母/监护人将被要求在首次陈述时参与，在 临床主治医师判定血常规包括全血细胞计数和血培养 对于那些患有神经综合征的患者，腰椎穿刺术在临床上也适用于患者的治疗。 医院实验室常规进行革兰氏染色、葡萄糖/蛋白质水平、细胞计数和细菌培养 (在有介质/试剂的情况下)从患者腰椎穿刺处获得的脑脊液(CSF) 和AFI一起。这项研究将通过使用基于ELISA的血清学测试来寻找病原体，并将 对样本进行一系列其他检测，以检测出病原体。 在我们的研究中，将对临床样本进行与AFI相关的各种病因的测试，如细菌 病原体(钩端螺旋体、沙门氏菌、布鲁氏菌、莱姆疏螺旋体、肺炎链球菌、流感嗜血杆菌、脑膜炎奈瑟氏菌、 志贺氏菌、弯曲杆菌等)、立克次体(丛林斑疹伤寒、斑点热群、埃立克氏菌、 无浆性等)和病毒(KFD、登革热、日本脑炎、西尼罗河病毒、基孔肯雅病毒、 森林脑炎病毒，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)聚合酶链条 将使用患者血液、脑脊液、咽拭子和粪便样本的聚合酶链式反应(PCR)和血清学分析 确定其他已知的可引起急性发热性疾病的病原体。临床样本也将被检测出 利用基于聚合酶链式反应序列的病原体发现技术发现未知病原体。 PHS 398/2590(06/09版)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