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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.
 
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