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CTRI Number  CTRI/2024/07/071069 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Understanding the burden and threat of tuberculosis, melioidosis and glanders. 
Scientific Title of Study   One-health approaches to understand the burden and threat of zoonotic tuberculosis, melioidosis and glanders in Uttar Pradesh, Karnataka and Haryana states. Multi-institute project. 
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 Chiranjay Mukhopadhyay 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Basic Science Building, 2nd Floor, Department of Microbiology, Kasturb Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chiranjay Mukhopadhyay 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Basic Science Building, 2nd Floor, Department of Microbiology, Kasturb Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India


KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chiranjay Mukhopadhyay 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Basic Science Building, 2nd Floor, Department of Microbiology, Kasturb Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India


KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi, India 
 
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  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shanmugasundaram K  ICAR-National Research Centre On Equines  1st floor, Department of Veterinary Pathology, Sirsa Road, Hisar - 125001, Haryana
Hisar
HARYANA 
9896481716

shanmuga02@gmail.com 
Dr Chiranjay Mukhopadhyay  Kasturba Medical College, Manipal  2nd Floor, Basic Science Building, Department of Microbiology, Kasturba Medical College, Manipal, Manipal Academy of Higher Eduction, Manipal, Karnataka, India
Udupi
KARNATAKA 
9845513057

chiranjay.m@manipal.edu 
Dr Madhu Sharma  Post Graduate Institute of Medical Sciences  1st floor, Division 61/9J,Med.Encl, Department of Microbiology, Rohtak, Haryan
Rohtak
HARYANA 
8052233703

madhusharma71@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Biomoedical Research Ethics Committee  Approved 
Ethical Committee of IAEC-ICAR-National Research Centre on Equines  Submittted/Under Review 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A249||Melioidosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Suspected melioidosis and tuberculosis cases for KAP study.
2. Confirmed melioidosis and tuberculosis cases for sample collection.
3. Glander positive serum samples. 
 
ExclusionCriteria 
Details  NIL 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To achieve the mentioned sample size.
2. Create a database on the targeted zoonotic diseases, detection, treatment, better prevention and patient management.
3. The outcome from KAP study will be used to develop recommendations at the grass root level to mitigate the burden of zoonotic disease transmission.  
Outcome 1: 24 weeks.
Outcome 2: 48 weeks.
Outcome 3: 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Metagenomics data will detect known, emerging & unknown or rare zoonotic pathogens of human & veterinary importance.
2. The outcome of this study will build a network within different countries connecting human & animal researchers.  
Outcome 1: 96 weeks.
Outcome 2: 120 weeks. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   05/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 the primary source of emerging human diseases. Of these, bovine tuberculosis (bTB), glanders and melioidosis are zoonotic infectious diseases of humans and animals. The presence of these zoonotic diseases in humans and animals in the country has been reported by unidirectional passive surveillance, mostly during outbreaks. Hence, the public health burden of bTB, melioidosis, glanders, associated risk factors, and the persistence of these zoonotic pathogens in the populations and environment is often underestimated in India. This is due to a lack of coordinated surveillance among human and animal health sectors. Therefore, the One Health (OH) approach through integrated human, animal and environment surveillance is essential to address the knowledge gap and better implementation of control strategies for zTB, glanders, and melioidosis. Hence, the multi-institutional proposal involving human and animal sectors has been formulated with the following objectives (i) To profile socio-demographic and associated risk factors in acquiring zTB, glanders and melioidosis in animals and humans, ii) Detection of bTB, glanders and melioidosis and their causative agents in humans, animals and environment by isolation, molecular, metagenomic and serological techniques and iii) Molecular epidemiology of isolates obtained from human, animal and environment. This will be the first OH study in the country to address the three important but neglected zoonotic diseases under one umbrella. The proposed work will be conducted in three states namely, Haryana, Karnataka and Uttar Pradesh. The outcome of this project will help in the timely detection, and better prevention of the targeted zoonotic diseases and the development of a control policy.
 
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