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
|
|
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
|
|
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. |