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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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