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临床试验/CTRI/2023/05/053013
CTRI/2023/05/053013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

Dr Winsley Rose10 个研究点 分布在 1 个国家目标入组 750 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
750
试验地点
10
主要终点
1 Age specific attack rate

研究概览

简要总结

Background

Febrile illness is the most common reason for seeking healthcare in India and is associated with substantial morbidity and mortality. Dengue virus and Chikungunya Virus have recently shown an expanding range, moving from urban to rural areas, plains to hilly terrain, and continue to circulate endemically across tropical and subtropical regions worldwide.

Objectives:

The primary objectives are to determine the incidence of acute febrile illness, incidence, and seroprevalence of Dengue over a period of 12 months. Secondary objectives are to estimate the incidence and seroprevalence of chikungunya and to estimate the proportion of acute febrile illnesses caused by other common causes such as malaria, typhoid, leptospirosis, and scrub typhus.

Methods:

Healthy individuals above 2 years of age from the Vellore HDSS area will be recruited in the study. 752 individuals with be enrolled in proportionate age bands in 5 clusters of 151 individuals each after informed consent if they fulfill all the inclusion criteria and none of the exclusion criteria. All these individuals will be followed up for 12 months from their date of enrolment. A baseline serosurvey for Dengue and Chikungunya will be performed and repeated at the end of the first year. During the follow-up period, all participants will be under weekly surveillance for the occurrence of fever. Any participant with a fever for more than two days will be visited and tested for dengue and chikungunya along with a complete blood count and rapid test for malaria. If the fever lasts for more than 10 days, tests for leptospira, typhoid, and scrub typhus will also be performed. All results will be provided to the participant. In the 3rd week after the onset of fever, convalescent serology will also be obtained for dengue and chikungunya. Apart from active surveillance, the participants can directly visit the study facility or telephonically contact the study team (passive surveillance). The economic burden due to dengue and chikungunya will also be analyzed.

Expected outcome:

We will be able to find the seroprevalence of dengue and chikungunya in the Vellore HDSS area and also the incidence of laboratory-confirmed dengue and chikungunya in those with acute febrile illness within the community.

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 Individuals currently residing and likely to stay till the end of one year in the study area 2 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 before enrolment for the cohort.

结局指标

主要结局

1 Age specific attack rate

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

2 Age-specific cumulative incidence of asymptomatic infections

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

3 Age-specific cumulative incidence of symptomatic events

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

4. Age Specific sero prevalence and seroincidence of neutralizing antibodies

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

5. Symptomatic proportion of cases (asymptomatic fraction)

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

6. Prevalence and incidence of Circulating serotypes

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

7. Population groups most at risk

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

8. Validity of IgG ELISA

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

9. Economic burden of Dengue and Chikungunya

时间窗: The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline

次要结局

未报告次要终点

研究者

发起方
Dr Winsley Rose
申办方类型
Other [self]

研究点 (10)

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