Community Based Surveillance to Estimate Incidence & Sero prevalence of Acute Febrile Illness with focus on Dengue & Chikungunya – A Prospective Multi-centric Cohort Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Ongoing fever episodes or history of AFI on or within 3 calendar days before enrolment for the cohort.
Outcomes
Primary Outcomes
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
Time Frame: Baseline and at the end of 12 months
Secondary Outcomes
- 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).)