| 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
|
|
|
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
|
|
|
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 |
|
|
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. |