| CTRI Number |
CTRI/2023/04/051355 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective cohort |
| Study Design |
Other |
|
Public Title of Study
|
fever illness surveillance with special attention to dengue and chikungunya |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini sharma |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 323 Department of community Medicine
Maulana Azad medical College
New Delhi
DELHI
11002
India |
| Phone |
|
| Fax |
|
| Email |
drnandini1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heena Lalwani |
| Designation |
Senior Project Manager |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 368
Department of community Medicine
Maulana Azad medical College
New Delhi
DELHI
11002
India |
| Phone |
7798624492 |
| Fax |
|
| Email |
heena.lalwani91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Lalwani |
| Designation |
Senior Project Manager |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 368
Department of community Medicine
Maulana Azad medical College
New Delhi
DELHI
11002
India |
| Phone |
7798624492 |
| Fax |
|
| Email |
heena.lalwani91@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIRAC
1st Floor ,MTNL Building ,9, Lodhi Rd, CGO Complex, Pragati Vihar, New Delhi, Delhi 110003
Phone: 011 2438 9600 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Sharma |
| Address |
Department of community medicine,
Maulana Azad Medical College
new delhi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Heena Lalwani |
Urban Health Centre (UHC), |
Urban Health Centre (UHC), First Floor, DGD Gokulpuri, B-Block,
Resettlement Colony, GokulPuri, Delhi -I 10094
North East
DELHI |
7798624492
heena.lalwani91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
apparently healthy individuals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
Ongoing fever episodes or history of AFI on or before enrolment for the cohort
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Age specific attack rate The proportion of individuals per age strata who show
Sero conversion between two rounds
2 Age-specific cumulative incidence of
asymptomatic infections
The proportion of individuals per age strata who show
seroconversion over 1 year but do not report any
symptoms suggestive of the infection during AFI/ILI
surveillance
3 Age-specific cumulative incidence of
symptomatic events
The proportion of individuals reported / diagnosed with
disease under surveillance
4 Age Specific sero prevalence and sero
incidence of neutralizing antibodies
The proportion of individuals showing presence of
neutralizing antibodies at baseline and at end line. |
at end of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Symptomatic proportion of cases
(asymptomatic fraction)
The proportion of individuals who show symptoms or
signs of Dengue / Chikungunya infection
6 Prevalence and incidence of Circulating
serotypes
The proportion of symptomatic and asymptomatic
cases with type of circulating serotype.
7 Population groups most at risk The identification of groups who are most vulnerable to
Dengue ad Chikungunya infection (e.g. age groups,
gender, occupation)
8 Validity of IgG ELISA The sensitivity and specificity of IgG ELISA will be
calculated against PRNT (Neutralizing antibodies). |
at end of one year |
|
|
Target Sample Size
|
Total Sample Size="752"
Sample Size from India="752"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
we propose to carry out a multi-centric, prospective
community-based cohort study to estimate the incidence of dengue and
chikunguniya in India, with the established DHS site, as one of the study
centres. This will be done through baseline enrollment and blood sample
collection of participants for indirect ELISA IgG testing and serotypes
identification..
Study design: Prospective cohort study
Objectives:
1. Primary
objective In the study area:
1. Estimate
Prospectively :
a. Incidence
rate of acute febrile illness episode during 12 months of follow up
b. Incidence
rate of symptomatic laboratory confirmed Dengue infection episodes during 12
months of follow up
c. Incidence of
Sero positivity based on IgG, IgM and neutralizing antibodies at 12 months
(Sero Negative for IgG, IgM or Neutralizing antibodies at baseline at
enrolment).
2. Secondary
objective:
1. Incidence
rate of symptomatic laboratory confirmed Chikungunya infection episodes during
12 months of follow up
2. Determine
the etiology of AFI due to other common causes of AFI (based on rapid
diagnostic or ELISA based laboratory diagnosis)
a. Malaria
b. Scrub typhus
c. Leptospirosis
d. Typhoid
3. Describe the
proportion of symptomatic versus asymptomatic or sub clinical infections of
dengue and chikungunya based on data obtained from primary objectives. 4.
Identify and describe the circulating serotypes of dengue and chikungunya in
the general population over a period of one year.
5. To assess
spatiotemporal trend of Dengue and Chikungunya infection over a period of 12
months.
6. Determine the durability of IgG, IgM and
Neutralizing antibodies in symptomatic individuals tested n positive for Dengue
and Chikungunya infection |