fever illness surveillance with special attention to dengue and chikungunya

Not yet recruiting

Conditions: apparently healthy individuals

Registration Number: CTRI/2023/04/051355

Lead Sponsor: Dr Nandini Sharma

Brief Summary: 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:

1. 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).

2. Secondaryobjective:

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

2. 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

3. 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.

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

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 752

Inclusion Criteria

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.

Exclusion Criteria

Ongoing fever episodes or history of AFI on or before enrolment for the cohort.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
seroconversion over 1 year but do not report any	at end of one year
symptoms suggestive of the infection during AFI/ILI	at end of one year
Age specific attack rate The proportion of individuals per age strata who show	at end of one year
surveillance	at end of one year
3 Age-specific cumulative incidence of	at end of one year
symptomatic events	at end of one year
The proportion of individuals reported / diagnosed with	at end of one year
disease under surveillance	at end of one year
4 Age Specific sero prevalence and sero	at end of one year
incidence of neutralizing antibodies	at end of one year
The proportion of individuals showing presence of	at end of one year
Sero conversion between two rounds	at end of one year
2 Age-specific cumulative incidence of	at end of one year
asymptomatic infections	at end of one year
The proportion of individuals per age strata who show	at end of one year
neutralizing antibodies at baseline and at end line.	at end of one year

Secondary Outcome Measures

Name	Time	Method
Symptomatic proportion of cases	(asymptomatic fraction)

Trial Locations

Locations (1): Urban Health Centre (UHC),
🇮🇳
East, DELHI, India
Urban Health Centre (UHC),
🇮🇳East, DELHI, India
Dr Heena Lalwani
Principal investigator
7798624492
heena.lalwani91@gmail.com