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Clinical Trials/CTRI/2024/07/071069
CTRI/2024/07/071069Not yet recruitingNot Applicable

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.

Indian Council of Medical Research3 sites in 1 country300 target enrollmentStarted: August 5, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
300
Locations
3
Primary Endpoint
1. To achieve the mentioned sample size.

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Suspected melioidosis and tuberculosis cases for KAP study.
  • Confirmed melioidosis and tuberculosis cases for sample collection.
  • Glander positive serum samples.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

1. To achieve the mentioned sample size.

Time Frame: Outcome 1: 24 weeks. | Outcome 2: 48 weeks. | Outcome 3: 24 weeks.

2. Create a database on the targeted zoonotic diseases, detection, treatment, better prevention and patient management.

Time Frame: Outcome 1: 24 weeks. | Outcome 2: 48 weeks. | Outcome 3: 24 weeks.

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.

Time Frame: Outcome 1: 24 weeks. | Outcome 2: 48 weeks. | Outcome 3: 24 weeks.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Dr Chiranjay Mukhopadhyay

Kasturba Medical College, Manipal

Study Sites (3)

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