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临床试验/CTRI/2023/06/053781
CTRI/2023/06/053781尚未招募不适用

Community Based Surveillance to Estimate Incidence & Sero prevalence of Acute Febrile Illness with focus on Dengue & Chikungunya – A Prospective Multi-centric Cohort Study.

SHARE INDIA1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2023年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
750
试验地点
1
主要终点
The primary outcome is estimation of the burden of diseases causing acute febrile illness with focus on Dengue & Chikungunya at community level & determine the seasonal variations and the rate of transmission in the incidence of acute febrile illnesses

研究概览

简要总结

In view of the rising threat of Dengue infections in the country, the incidence needs to be estimated using cohort study design. Various initiatives have been taken up -both by private and public entities for developing novel vaccines for tackling dengue fever for which sero-surveillance is necessary. Thus this study will support these initiatives to understand the burden of the disease in the county .We are proposing this community based prospective cohort study   under DBT’s Resource of Indian Vaccine Epidemiology Network (DRIVEN) funded by National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology India. The proposed study aims to assess the incidence of dengue fever over a period of 1 year. Although the sample size is not powered for other disease indications (Chikungunya, Malaria, Typhoid, Leptospirosis, Scrub typhus), the study will also estimate the incidence of Chikungunya, Malaria, Typhoid, Leptospirosis, Scrub typhus and proportion of asymptomatic infections, secondary infections as well as describe the circulating dengue and Chikungunya serotypes in the study area by lab confirmation of fever cases during the study period of one year. The epidemiological data generated in the study will be useful in designing future vaccine trials, and conducting the trials and their impact assessment.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Study will be carried out in individuals above 2 Years of age.
  • •2.Individuals currently residing and likely to stay till the end of one year in the study area.
  • •3.Consented to participate in both sections of the study (Sero Prevalence and AFI Surveillance) and follow all study procedures.

排除标准

  • •Ongoing fever episodes or history of AFI on or within 3 calendar days before enrolment for the cohort.

结局指标

主要结局

The primary outcome is estimation of the burden of diseases causing acute febrile illness with focus on Dengue & Chikungunya at community level & determine the seasonal variations and the rate of transmission in the incidence of acute febrile illnesses

时间窗: Baseline and at the end of 12 months

次要结局

  • 1.The identification of groups who are most vulnerable to Dengue & Chikungunya infection (e.g. age groups, gender, occupation)(2.The sensitivity and specificity of IgG ELISA will be calculated against PRNT (Neutralizing antibodies).)

研究者

发起方
SHARE INDIA
申办方类型
Research institution

研究点 (1)

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