| CTRI Number |
CTRI/2023/05/053025 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Acute Febrile Illness Surveillance |
|
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 |
Dr N K Arora |
| Designation |
Executive Director |
| Affiliation |
The INCLEN Trust International |
| Address |
Mawngap Rim Mawphlang East
Khasi Hills Meghalaya - 793121 India
East Khasi Hills
MEGHALAYA
793121
India |
| Phone |
9582366630 |
| Fax |
|
| Email |
nkarora@inclentrust.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Agarwal |
| Designation |
Deputy Director |
| Affiliation |
The INCLEN Trust International |
| Address |
Mawngap Rim Mawphlang East
Khasi Hills Meghalaya - 793121 India
East Khasi Hills
MEGHALAYA
793121
India |
| Phone |
9582366630 |
| Fax |
|
| Email |
abhishek.agarwal@inclentrust.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Agarwal |
| Designation |
Deputy Director |
| Affiliation |
The INCLEN Trust International |
| Address |
Mawngap Rim Mawphlang East
Khasi Hills Meghalaya - 793121 India
East Khasi Hills
MEGHALAYA
793121
India |
| Phone |
9582366630 |
| Fax |
|
| Email |
abhishek.agarwal@inclentrust.org |
|
|
Source of Monetary or Material Support
|
| Biotechnology Industry Research Assistance Council (BIRAC)
1st Floor ,MTNL Building ,9 , CGO Complex, Lodhi Road, New Delhi-110003
(Next to Scope Complex, Infront of Gate no. 13, JLN Stadium) |
|
|
Primary Sponsor
|
| Name |
BIRAC |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Abhishek Agarwal |
INCLEN SOMAARTH Mawphlang |
Mawngap Rim Mawphlang East
Khasi Hills Meghalaya - 793121 India
East Khasi Hills
MEGHALAYA |
9582366630
abhishek.agarwal@inclentrust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INCLEN SOMAARTH Mawphlang Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(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 procedures. |
|
| ExclusionCriteria |
| Details |
Ongoing fever episodes or history of AFI on or within 3 calendar days 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
Age-specific cumulative incidence of asymptomatic Dengue and Chikungunya infections
Age-specific cumulative incidence of symptomatic Dengue and Chikungunya events
Age Specific sero prevalence and sero incidence of neutralizing antibodies
Symptomatic proportion of cases (asymptomatic fraction) |
13 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Acute febrile Illnesses - Malaria, Typhoid, Leptospirosis and Scrub typhus |
13 months |
|
|
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)
|
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="0"
Months="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The proposed study is planned with an objective to estimate the incidence of acute febrile illnesses in the community, follow the febrile cases through surveillance to estimate the incidence of Dengue and Chikungunya at community level. The study is planned to be carried among 10 DRIVEN network sites and in 7520 individuals (752 / site). The study will be carried in two phases - Phase 1 - Sero survey - In this two round (Baseline and end line) of sero survey shall be carried for 750 individuals distributed across the ages. In Phase 2 of the study Fever surveillance will be carried where the individual will be tested for Dengue and Chikungunya at different time points. As part of participant care and understand the prevalence of locally endemic diseases the participants shall also be tested for Malaria, Typhoid, Leptospirosis and Scrub typhus. |