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临床试验/CTRI/2023/04/051355
CTRI/2023/04/051355尚未招募不适用

The development of a Health and demographic surveillance(DHS) site with focus on epidemiological survey of dengue and chikungunya in an urban resettlement colony and slum in Delhi

Dr Nandini Sharma1 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2023年4月20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
seroconversion over 1 year but do not report any

研究概览

简要总结

we propose to carry out a multi-centric, prospectivecommunity-based cohort study to estimate the incidence of dengue andchikunguniya in India, with the established DHS site, as one of the studycentres. This will be done through baseline enrollment and blood samplecollection of participants for indirect ELISA IgG testing and serotypesidentification..

Study design: Prospective cohort study

Objectives:

  1. Primaryobjective In the study area:

  2. EstimateProspectively :

a. Incidencerate of acute febrile illness episode during 12 months of follow up

b. Incidencerate of symptomatic laboratory confirmed Dengue infection episodes during 12months of follow up

c. Incidence ofSero positivity based on IgG, IgM and neutralizing antibodies at 12 months(Sero Negative for IgG, IgM or Neutralizing antibodies at baseline atenrolment).

  1. Secondaryobjective:

  2. Incidencerate of symptomatic laboratory confirmed Chikungunya infection episodes during12 months of follow up

  3. Determinethe etiology of AFI due to other common causes of AFI (based on rapiddiagnostic or ELISA based laboratory diagnosis)

a. Malaria

b. Scrub typhus

c. Leptospirosis

d. Typhoid

  1. Describe theproportion of symptomatic versus asymptomatic or sub clinical infections ofdengue and chikungunya based on data obtained from primary objectives. 4.Identify and describe the circulating serotypes of dengue and chikungunya inthe general population over a period of one year.

  2. To assessspatiotemporal trend of Dengue and Chikungunya infection over a period of 12months.

  3. Determine the durability of IgG, IgM andNeutralizing antibodies in symptomatic individuals tested n positive for Dengueand Chikungunya infection

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Individuals currently residing and likely to stay till the end of one year in the study area. 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

seroconversion over 1 year but do not report any

时间窗: at end of one year

symptoms suggestive of the infection during AFI/ILI

时间窗: at end of one year

disease under surveillance

时间窗: at end of one year

Age specific attack rate The proportion of individuals per age strata who show

时间窗: at end of one year

4 Age Specific sero prevalence and sero

时间窗: at end of one year

surveillance

时间窗: at end of one year

3 Age-specific cumulative incidence of

时间窗: at end of one year

symptomatic events

时间窗: at end of one year

The proportion of individuals reported / diagnosed with

时间窗: at end of one year

incidence of neutralizing antibodies

时间窗: at end of one year

The proportion of individuals showing presence of

时间窗: at end of one year

Sero conversion between two rounds

时间窗: at end of one year

2 Age-specific cumulative incidence of

时间窗: at end of one year

asymptomatic infections

时间窗: at end of one year

The proportion of individuals per age strata who show

时间窗: at end of one year

neutralizing antibodies at baseline and at end line.

时间窗: at end of one year

次要结局

  • Symptomatic proportion of cases((asymptomatic fraction))

研究者

发起方
Dr Nandini Sharma
申办方类型
Other [self]

研究点 (1)

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