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CTRI Number  CTRI/2023/02/050054 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Community-based Actions to Tackle the Problem of Antibiotic Resistance 
Scientific Title of Study   Community-based Intervention to Address Antibiotic Resistance: An Embedded Mixed-methods Interventional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arista Lahiri 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technology Kharagpur 
Address  Room No. 735, Dr. B. C. Roy Multi-Speciality Medical Research Centre, Life Science Building, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, India

Medinipur
WEST BENGAL
721302
India 
Phone    
Fax    
Email  alpublications2016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arista Lahiri 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technology Kharagpur 
Address  Room No. 735, Dr. B. C. Roy Multi-Speciality Medical Research Centre, Life Science Building, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, India

Medinipur
WEST BENGAL
721302
India 
Phone    
Fax    
Email  alpublications2016@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arista Lahiri 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technology Kharagpur 
Address  Room No. 735, Dr. B. C. Roy Multi-Speciality Medical Research Centre, Life Science Building, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, India

Medinipur
WEST BENGAL
721302
India 
Phone    
Fax    
Email  alpublications2016@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, Post Box - 4911, New Delhi, Pin - 110029 
Type of Sponsor  Research institution 
 
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 
Sweety Suman Jha  Kolkata (Urban)  Kidderpore, Tangra, Topsia, and Dhapa area
Kolkata
WEST BENGAL 
8017355170

swty.jha06@gmail.com 
Arista Lahiri  Paschim Medinipur (Rural)  Kharagpur I and Kharagpur II blocks
Medinipur
WEST BENGAL 
9051010215

alpublications2016@gmail.com 
Arista Lahiri  Paschim Medinipur (Urban)  Kharagpur Municipality Area
Medinipur
WEST BENGAL 
9051010215

alpublications2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Indian Institute of Technology Kharagpur  Approved 
Indian Institute of Technology Kharagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Those having symptoms of infections, e.g., fever, productive cough, loose stool, burning micturition, during last 3 months. 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioral intervention package  Duration: Intervention will start 1 month after the baseline survey and will continue for 2 months. Components: •Intervention will be a behavioral intervention package, targeting awareness, perceived severity, and perceived susceptibility regarding the issue of Antibiotic resistance. •Awareness generation regarding antibiotic resistance and appropriate practices for antibiotic use, through public meetings in the intervention clusters. •Posters and IEC materials to be displayed in the local dispensaries and health centers, highlighting the perils of antibiotic resistance and promoting proper antibiotic practices among the beneficiaries •House-to-house awareness campaign with pamphlets will be conducted by field-staffs recruited under this project. •The intervention package will be further modified content-wise with the findings from the qualitative part of the study.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Individuals suffering from any symptoms of systemic infection (e.g., fever, pain in the abdomen, diarrhea, urinary problems, cough and cold, etc.) within the last 3 months of the field survey. 
 
ExclusionCriteria 
Details  1. Critically ill, cancer patients, or bed-ridden patients
2. Individuals diagnosed to be immunocompromised
3. Individuals on immunosuppressive therapy
4. Respondents diagnosed with any psychiatric illness 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The intervention package proposed is expected to improve the awareness of the participants on appropriate use of antibiotics, and on the adverse effects of antibiotic resistance. It is expected that the proportion of antibiotic resistance will not increase further in the intervention clusters as compared to the control clusters.   3 months after the intervention delivery 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that the proportion of antibiotic resistance will not increase further in the intervention clusters as compared to the control clusters.   3 to 4 months after the intervention delivery 
 
Target Sample Size   Total Sample Size="3800"
Sample Size from India="3800" 
Final Enrollment numbers achieved (Total)= "4200"
Final Enrollment numbers achieved (India)="4200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/02/2023 
Date of Study Completion (India) 15/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/07/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background:

Antibiotic resistance is a global threat that occurs naturally but misuse and overuse of antibiotics in humans and animals is accelerating the process and requires ‘one health’ approach to mitigate the situation.

Novelty:

Considering ‘one health’ approach in the proposed study, it is the novel concept for implementation in Indian context. The proposed study would generate evidence on burden of antibiotic resistance, awareness and practices of proper antibiotic consumption among community members in West Bengal. The intervention package proposed in this study will be a novel intervention, which can be integrated with the existing healthcare delivery system as well.

Objectives:

To evaluate the changes in awareness and practices related to antibiotic consumption, and the proportion of antibiotic resistance after the intervention.

Methods:

The proposed study will be an embedded mixed methods interventional community-based study to be conducted in greater Kolkata region and West Medinipur district among adults (≥ 18 years of age) who will give consent for participation, and residing in a particular area for more than 10 years. Intervention in the form of behavioral intervention package, targeting awareness, perceived severity, and perceived susceptibility regarding the issue of Antibiotic resistance will be developed and implemented. Data collection in the form of survey, observation, in-depth interview, collection of human, animal and environment sample will be carried out.

Expected outcome:

The intervention package proposed is expected to improve the awareness of the participants on appropriate use of antibiotics, and on the adverse effects of antibiotic resistance.

 
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