CTRI Number |
CTRI/2023/06/053781 [Registered on: 12/06/2023] Trial Registered Prospectively |
Last Modified On: |
09/06/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
A Community Based Study to determine the burden of fever cases with focus on Dengue & Chikungunya infections |
Scientific Title of Study
|
Community Based Surveillance to Estimate Incidence & Sero prevalence of Acute Febrile Illness with focus on Dengue & Chikungunya – A Prospective Multi-centric Cohort Study.
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
D Shailendra |
Designation |
Professor |
Affiliation |
MediCiti Institute of Medical Sciences |
Address |
Department of Pharmacology
Paraclinical Division
Room No.1, MediCiti Institute of Medical Sciences,
Telangana State Ghanpur Village,Medchal Mandal, Medchal TELANGANA 501401 India |
Phone |
9849145768 |
Fax |
08418256234 |
Email |
shailendra962@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
D Shailendra |
Designation |
Professor |
Affiliation |
MediCiti Institute of Medical Sciences |
Address |
Department of Pharmacology,
Paraclinical Division,
Room No.1,
MediCiti Institute of Medical Sciences, Ghanpur village,Medchal (mandal),
Medchal TELANGANA 501401 India |
Phone |
9849145768 |
Fax |
08418256234 |
Email |
shailendra962@gmail.com |
|
Details of Contact Person Public Query
|
Name |
D Shailendra |
Designation |
Professor |
Affiliation |
MediCiti Institute of Medical Sciences |
Address |
Department of Pharmacology,
Paraclinical Division,
Room No.1,
MediCiti Institute of Medical Sciences,
Ghanpur village,Medchal (mandal), Medchal TELANGANA 501401 India |
Phone |
9849145768 |
Fax |
08418256234 |
Email |
shailendra962@gmail.com |
|
Source of Monetary or Material Support
|
National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC),1st Floor, MTNL Building,
9, CGO Complex, Lodhi Road,
New Delhi – 110003
|
|
Primary Sponsor
|
Name |
SHARE INDIA |
Address |
SHARE INDIA
MediCiti Institute of Medical Sciences Campus,Ghanpur Village,Medchal mandal
Medchal District
Telangana State 501401 |
Type of Sponsor |
Research institution |
|
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 |
Nitin Desai |
SHARE (Society for Health Allied Research and Education) |
MediCiti Institute of Medical Sciences campus,Medchal Mandal
Medchal District
Telangana State 501401 Medchal TELANGANA |
9985820831
nitincdesai@shareindia.org |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MediCiti Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Health human volunteers will be enrolled into the study and followed up weekly for documenting any episodes of acute fever for investigation and management |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
70.00 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 study 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 |
The primary outcome is estimation of the burden of diseases causing acute febrile illness with focus on Dengue & Chikungunya at community level & determine the seasonal variations and the rate of transmission in the incidence of acute febrile illnesses |
Baseline and at the end of 12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.The identification of groups who are most vulnerable to Dengue & Chikungunya infection (e.g. age groups, gender, occupation)
2.The sensitivity and specificity of IgG ELISA will be calculated against PRNT (Neutralizing antibodies).
3.The cost of illness of a case of dengue fever, chikungunya fever and dengue hemorrhagic fever will be calculated for both hospitalized and ambulatory
cases
|
all secondary outcomes will be assessed at the end of one year from baseline |
|
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)
|
21/06/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
"none yet" |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In view of the rising threat of Dengue infections in the country, the incidence needs to be estimated using cohort study design. Various initiatives have been taken up -both by private and public entities for developing novel vaccines for tackling dengue fever for which sero-surveillance is necessary. Thus this study will support these initiatives to understand the burden of the disease in the county .We are proposing this community based prospective cohort study under DBT’s Resource of Indian Vaccine Epidemiology Network (DRIVEN) funded by National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology India. The proposed study aims to assess the incidence of dengue fever over a period of 1 year. Although the sample size is not powered for other disease indications (Chikungunya, Malaria, Typhoid, Leptospirosis, Scrub typhus), the study will also estimate the incidence of Chikungunya, Malaria, Typhoid, Leptospirosis, Scrub typhus and proportion of asymptomatic infections, secondary infections as well as describe the circulating dengue and Chikungunya serotypes in the study area by lab confirmation of fever cases during the study period of one year. The epidemiological data generated in the study will be useful in designing future vaccine trials, and conducting the trials and their impact assessment.
|