CTRI Number |
CTRI/2023/05/053013 [Registered on: 22/05/2023] Trial Registered Prospectively |
Last Modified On: |
22/05/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
A cohort study to study fever in the community with focus on Dengue and Chikungunya in India |
Scientific Title of Study
|
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 |
Trial Acronym |
DRIVEN 2020 |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Winsley Rose |
Designation |
Professor |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Pediatrics (Unit-3), Christian Medical College,
Vellore
Vellore TAMIL NADU 632004 India |
Phone |
04162283343 |
Fax |
|
Email |
winsleyrose@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Winsley Rose |
Designation |
Professor |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Pediatrics (Unit-3), Christian Medical College,
Vellore
TAMIL NADU 632004 India |
Phone |
04162283343 |
Fax |
|
Email |
winsleyrose@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Winsley Rose |
Designation |
Professor |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Pediatrics (Unit-3), Christian Medical College,
Vellore
TAMIL NADU 632004 India |
Phone |
04162283343 |
Fax |
|
Email |
winsleyrose@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC) |
|
Primary Sponsor
|
Name |
Dr Winsley Rose |
Address |
Dr Winsley Rose, Professor, Dept of Pediatrics (Unit-3), Christian
Medical College, Vellore Tamil Nadu 632004 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 10 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Yalamanchili Padmasri |
Andhra Medical College Visakhapatnam |
BIRAC-DDESS Field Office, Rural Health Center, Simhachalam, Visakhapatnam, 530028 Visakhapatnam ANDHRA PRADESH |
9848072087
padmasriyalamanchili@yahoo.co.in |
Dr Temsunaro Rongsen Chandola |
Centre for Health Research and Development - Society of Applied Studies |
680, Gali No. 5, Nai Basti, Devli, New Delhi-110080 New Delhi DELHI |
9899226760
naro@sas.org.in |
Dr Winsley Rose |
Christian Medical College Vellore |
Department of
Paediatrics (Unit-3), Ida
Scudder Road, CMC
Vellore,632004 Vellore TAMIL NADU |
04162283343
winsleyrose@cmcvellore.ac.in |
Dr Sanghmitra Pati |
ICMR, Regional Medical Research Centre, Bhubaneswar |
RMRC, Nalco Square, PO-SE Railway complex, Bhubaneshwar, Orissa-751023 Khordha ORISSA |
8763590440
drsanghamitra12@gmail.com |
Dr Nandini Sharma |
Maulana Azad Medical College, New Delhi |
Urban Health Center, First floor, Delhi Government Dispensary, Block A, Gokalpuri, Delhi- 110094 East DELHI |
9968604245
drnandini1@gmail.com |
Dr R Prabu |
National Institute of Epidemiology, Chennai |
Model Rural Health Research Unit, Kallur-PHC Campus, Nadukallur Village, Tirunelveli District, Tamil Nadu Tirunelveli TAMIL NADU |
8072479674
driven.nie@gmail.com |
Dr Anil J Purty |
Pondicherry Institute of Medical Sciences, Puducherry |
PIMS, rural health centre 261/1, keezhputhupattu panchayat, anaichikuppam, villupuram district, tamilnadu - 605014. Viluppuram TAMIL NADU |
9894078814
purtyanil90@gmail.com |
Dr D Shailendra |
SHARE INDIA |
Medi Citi Institute of Medical Sciences Campus Ghanpur Village, Medchal (Mandal and District) Hyderabad Telangana 501401 Hyderabad TELANGANA |
9849145768
shailendra962@gmail.com |
Dr Shikha Dixit |
The INCLEN Trust International, Palwal |
SOMAARTH DDESS
H. Khata No,1460/1582, Village – Mitrol, NH 19, Aurangabad, Delhi Agra Highway, Palwal
Haryana- 121105 Faridabad HARYANA |
9810618897
shikha.dixit@inclentrust.org |
Dr N K Arora |
The INCLEN Trust International, Shillong |
SOMAARTH-DDESS, Mawngap Rim village, Mawphlang block, East Khasi Hills District, Meghalaya: 793 121 East Khasi Hills MEGHALAYA |
7005282065
nkarora@inclentrust.org |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board Christian Medical College Vellore Tamil Nadu |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: A920||Chikungunya virus disease, (2) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
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. |
|
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 |
1 Age specific attack rate
2 Age-specific cumulative incidence of asymptomatic infections
3 Age-specific cumulative incidence of symptomatic events
4. Age Specific sero prevalence and seroincidence of neutralizing antibodies
5. Symptomatic proportion of cases (asymptomatic fraction)
6. Prevalence and incidence of Circulating serotypes
7. Population groups most at risk
8. Validity of IgG ELISA
9. Economic burden of Dengue and Chikungunya
|
The AFI study will be conducted for a period of 12 months with serosurvey for dengue and chikungunya at baseline and endline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="750" Sample Size from India="750"
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)
|
01/06/2023 |
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="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
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. |