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临床试验/CTRI/2023/05/053025
CTRI/2023/05/053025尚未招募不适用

Community based Surveillance to estimate incidence and sero prevalence of acute febrile illness with focus on Dengue and Chikungunya – A prospective multi-centric cohort Study.

BIRAC1 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2023年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
752
试验地点
1
主要终点
Age specific attack rate

研究概览

简要总结

The proposed study is planned with an objective to estimate the incidence of acute febrile illnesses in the community, follow the febrile cases through surveillance to estimate the incidence of Dengue and Chikungunya at community level. The study is  planned to be carried among 10 DRIVEN network sites and in 7520 individuals (752 / site). The study will be carried in two phases - Phase 1 - Sero survey - In this two round (Baseline and end line) of sero survey shall be carried for 750 individuals distributed across the ages. In Phase 2 of the study Fever surveillance will be carried where the individual will be tested for Dengue and Chikungunya at different time points. As part of participant care and understand the prevalence of locally endemic diseases the participants shall also be tested for Malaria, Typhoid, Leptospirosis and Scrub typhus.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 99.00 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 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

Age specific attack rate

时间窗: 13 Months

Age-specific cumulative incidence of asymptomatic Dengue and Chikungunya infections

时间窗: 13 Months

Age-specific cumulative incidence of symptomatic Dengue and Chikungunya events

时间窗: 13 Months

Age Specific sero prevalence and sero incidence of neutralizing antibodies

时间窗: 13 Months

Symptomatic proportion of cases (asymptomatic fraction)

时间窗: 13 Months

次要结局

  • Incidence of Acute febrile Illnesses - Malaria, Typhoid, Leptospirosis and Scrub typhus(13 months)

研究者

发起方
BIRAC
申办方类型
Government funding agency

研究点 (1)

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