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

描述(由申请人提供)：实验室诊断学的进步极大地提高了对急性发热病(AFI)的感染病因的了解，例如持续一周以上的发烧，包括印度西加特地区的凯萨努尔森林病(KFD)、钩端螺旋体病、立克次体疾病(如丛林斑疹伤寒、登革热和莱姆病)。 这项研究旨在描述印度卡纳塔克邦、喀拉拉邦和泰米尔纳德邦西加特地区的次区域医院患者中急性发热病(AFI)的感染原因。这项研究将重点研究AFI的细菌、立克次体和病毒原因。根据过去的患者数量，在研究的第一阶段或第一年，在两个研究地点之间的一年时间里，估计将有大约400名患者入选(即符合研究病例定义)。这项研究计划在下贺核心区展开 第一年在卡纳塔克邦地区优化资源，并在第二年推广到喀拉拉邦，第三年推广到泰米尔纳德邦。喀拉拉邦和泰米尔纳德邦的新增人数将分别为200人。因此，在第三年结束时，本研究的学生人数应为800人。 患者和/或父母/监护人将被要求在最初出现时参与，在治疗临床医生确定临床上需要对患者进行包括完整血细胞计数和血培养的血液分析以及神经综合征腰椎穿刺术后，患者将被要求参加。医院实验室通常对AFI患者通过腰椎穿刺术获得的脑脊液(CSF)进行革兰氏染色、葡萄糖/蛋白质水平、细胞计数和细菌培养(如果有介质/试剂)。这项研究将通过使用基于ELISA的血清学测试来寻找病原体，并对样本进行一系列其他测试，以导致病原体检测。 在我们的研究中，将对临床样本进行与AFI相关的各种病原体的检测，例如细菌病原体(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)、立克次体生物群(丛枝伤寒、斑点热群、埃利希菌、无浆菌等)。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)对患者血液、脑脊液、咽拭子和粪便样本的聚合酶链式反应(PCR)和血清学分析将用于识别其他已知的导致急性发热性疾病的病原体。临床样本还将使用基于聚合酶链式反应序列的病原体发现技术进行未知病原体检测。

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.