| CTRI Number |
CTRI/2023/04/051805 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
18/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Community fever surveillance for incidence of Dengue and Chikungunya |
|
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 |
AFI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Temsunaro RongsenChandola |
| Designation |
Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
ID Division, Ground Floor
45, Kalu Sarai New Delhi
South West
DELHI
110016
India |
| Phone |
46043751 |
| Fax |
|
| Email |
naro@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Temsunaro RongsenChandola |
| Designation |
Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
ID Division, Ground Floor
45, Kalu Sarai New Delhi
South West
DELHI
110016
India |
| Phone |
46043751 |
| Fax |
|
| Email |
naro@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Temsunaro RongsenChandola |
| Designation |
Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
ID Division, Ground Floor
45, Kalu Sarai New Delhi
South West
DELHI
110016
India |
| Phone |
46043751 |
| Fax |
|
| Email |
naro@sas.org.in |
|
|
Source of Monetary or Material Support
|
| National Biopharma Mission, Biotechnology Industry Research Assistance Council |
|
|
Primary Sponsor
|
| Name |
National Biopharma Mission, Biotechnology Industry Research Assistance Council |
| Address |
1st Floor, MTNL Building, 9, CGO Complex, Lodhi Road, New Delhi – 110003 |
| 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 |
| Temsunaro Rongsen Chandola |
Centre for Health Research and Development, Society for Applied Studies |
680, Gali Number 5, Nai Basti, Devli
South
DELHI |
46043751
naro@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Centre for Health Research and DevelopmentSociety for Applied Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals currently residing and likely to stay till the end of one year in the study area and consent 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 |
| Incidence of AFI and lab confirmed dengue infection. |
After 12 months of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of lab-confirmed chikungunya infection. |
After 12 months of follow up |
|
|
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)
|
05/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
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 expected to determine the burden of diseases causing acute febrile illness with focus on Dengue and Chikungunya at community level and monitor to estimate the seasonal variations and rate of transmission in the incidence of disease, Risk factors for infection can be identified which might inform future control strategies. The serial surveys in the same set of individuals will help in measuring the antibody levels over a period of time and understand the proportion of individuals who are able to mount a neutralization response and the duration for which immunity lasts after infection.
The cost per case of Dengue (including Dengue Haemmohagic fever) and Chikungunya fever reported from the established cohort will be calculated by summing the following costs: (1) direct medical costs – costs directly attributable to patient care. It will include costs for hospitalization and cost of an ambulatory visit in public and private settings (including professional services, medical inputs, medical drugs and related products, as well as laboratory tests); (2) direct non-medical costs – costs directly attributable to illness but are not involved in direct purchase of medical services. It will include food, lodging and travel expenses incurred during the period of treatment (3) indirect costs (to the patient and their family) resulting from loss of productivity and loss of earnings. All costs will be calculated in Indian Rupees (INR). |