GH13-003: Hospital - Based Surveillance of Acute Febrile Illness in Western Ghat Region of

描述（由申请方提供）：实验室诊断学的进步极大地增强了对急性发热性疾病（AFI）（如持续时间超过一周的发热，包括Kyasanur森林病（KFD）、钩端螺旋体病、立克次体病（如恙虫病）、登革热和印度西加特地区的莱姆病）的感染病因学的理解。 本研究旨在描述印度西加特地区（包括卡纳塔克邦、喀拉拉邦和泰米尔纳德邦）分区医院急性发热性疾病（AFI）患者的感染原因。这项研究将集中在AFI的细菌，立克次体和病毒原因。根据历史患者数量，估计将入组约400例患者（即，符合研究病例定义）。这项研究计划在希莫加的核心地区展开 卡纳塔克邦区在第一年优化资源，并推出它在第二年和泰米尔纳德邦的喀拉拉邦在第三年。来自喀拉拉邦和泰米尔纳德邦的新增人口将各为200人。因此，在第3年结束时，研究中的摄入量应为800。 在治疗临床医生确定血液特征（包括全血细胞计数和血培养）以及神经系统综合征腰椎穿刺在临床上适用于患者管理后，将要求患者和/或父母/监护人在首次就诊时参与。医院实验室常规对通过腰椎穿刺从AFI患者中获得的脑脊液（CSF）进行革兰氏染色、葡萄糖/蛋白水平、细胞计数和细菌培养（如果培养基/试剂可用）。这项研究将通过使用基于ELISA的血清学试验寻找病原体，并对标本进行一系列其他试验以进行病原体检测。 在我们的研究中，临床样本将被检测与AFI相关的各种病因，如细菌病原体（钩端螺旋体、沙门氏菌、布鲁氏菌、莱姆病螺旋体、沙门氏菌）。pneumoniae、流感嗜血杆菌、N.脑膜炎、志贺氏菌、弯曲杆菌等）、立克次氏体群生物体（恙虫病、斑点热群、埃立克体、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）将使用患者血液、CSF、咽拭子和粪便样本的聚合酶链反应（PCR）和血清学分析来识别已知可引起急性发热性疾病的其他病原体。还将使用基于PCR序列的病原体发现技术检测临床样本中的未知病原体。

DESCRIPTION (provided by the applicant): 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 secon y ear 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 presen tation, 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.