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CTRI Number  CTRI/2024/02/062556 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   One Health approach for management of human anthrax disease 
Scientific Title of Study   “One Health” approach for elimination of human anthrax from a tribal district of Odisha: a randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debdutta Bhattacharya 
Designation  Scientist-E 
Affiliation  ICMR Regional Medical Research Centre Bhubaneswar 
Address  Room No 10, OPD Building, ICMR RMRC Chandrasekharpur, Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751023
India 
Phone  9886126077  
Fax    
Email  drdebdutta.bhattacharya@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Debdutta Bhattacharya 
Designation  Scientist-E 
Affiliation  ICMR Regional Medical Research Centre Bhubaneswar 
Address  Room No 10, OPD Building, ICMR RMRC Chandrasekharpur, Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751023
India 
Phone  9886126077  
Fax    
Email  drdebdutta.bhattacharya@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Debdutta Bhattacharya 
Designation  Scientist-E 
Affiliation  ICMR Regional Medical Research Centre Bhubaneswar 
Address  Room No 10, OPD Building, ICMR RMRC Chandrasekharpur, Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751023
India 
Phone  9886126077  
Fax    
Email  drdebdutta.bhattacharya@yahoo.co.in  
 
Source of Monetary or Material Support  
ECD Division, ICMR New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
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 
Dr Debdutta Bhattacharya  ICMR RMRC Bhubaneswar  Room No. 10, OPD Building, ICMR-RMRC, Chandrasekharpur, Bhubaneswar
Khordha
ORISSA 		 9886126077

drdebdutta.bhattacharya@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants will be selected based on the eligibility criteria: a) Should be an adult (age above 18 years) and a permanent resident of Koraput district, b) willing to participate in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants will be selected based on the eligibility criteria: a) Should be an
adult (age above 18 years) and a permanent resident of Koraput district, b) willing to participate in the study. 
 
ExclusionCriteria 
Details  a) Cognitive impairment, b) having onset symptoms or infected with any of the communicable disease which can be spread through nasal or mouth droplets 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Our primary outcome is to assess the KAP of the community across the two arms at the end of the study. So, the unit of study is a household. To achieve this, we shall do cluster sampling. Interventions will be planned and implemented in the intervention district whereas only baseline and end line survey will be carried in the control district. For qualitative inputs we shall be conducting the IDIs and FGDs till saturation of information achieved (Estimated 40 IDI & 8 FGD). We will be using purposive sampling for qualitative interviews.  Baseline at the start of the study and Endline at the end. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome includes assessment of disease burdens, patterns, knowledge, prevalence, and practices among the identified stakeholders from the departments of health, veterinary, environment/forest, and the community; and to evaluate the effectiveness of the interventions among the study population on anthrax burden in the control and intervention district along with cost-benefit analysis of interventions.  Baseline at the start of the study and Endline at the end. 
 
Target Sample Size   Total Sample Size="1560"
Sample Size from India="1560" 
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)   19/02/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
      Zoonoses are recognized as a major concern in developing nations, in need of a resolution. It is commonly agreed that the detection, management, and elimination of zoonotic diseases require joint efforts from the animal and human health sectors. Joint monitoring systems such as “One Health” strategy are the most efficient and reliable means of addressing zoonotic diseases such as anthrax in low-income countries. The One Health approach is already found to have significance when implemented to tackle the newly emerging diseases like Middle East respiratory syndrome, avian flu (H5N1), swine flu (H1N1), Ebola and Zika virus. Management and effective control of anthrax through One Health concept is described as a highly demanding approach although it needs a robust implementation globally. Over the last 15 years, 10 districts out of 30 revenue districts in Odisha have experienced outbreaks of human anthrax with 1208 cases and 436 deaths [IDSP, Odisha, 2016]. Among those affected districts, Koraput has more than 300 human anthrax cases including 10 deaths over the past 6 years. Almost all the cases came from a group of indigenous tribes involved in handling and consuming animal carcasses. Therefore, this implementation research project is planned in the district of Koraput using the "One Health" approach to demonstrate the feasibility for the elimination of human anthrax cases in three years. To compare the effectiveness of the proposed intervention we will be taking up another endemic district Sundargarh as control group.
 
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