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CTRI Number  CTRI/2025/05/087858 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring knowledge and awareness of AMR among the general population in Delhi 
Scientific Title of Study   Exploring knowledge and awareness of antimicrobial resistance (AMR) among the general population in Delhi: A cross-sectional study 
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 Shivani Rao  
Designation  ASSOCIATE PROFESSOR 
Affiliation  Maulana Azad Medical College 
Address  Department of Community Medicine, Maulana Azad Medical College, New Delhi

Central
DELHI
110002
India 
Phone  9650729724  
Fax    
Email  shivani.idsp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srishty 
Designation  Post Graduate  
Affiliation  Maulana Azad Medical College 
Address  Department of Community Medicine, Maulana Azad Medical College, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi 110002
Central
DELHI
110002
India 
Phone  09990640012  
Fax    
Email  srishtyrajaura2530@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srishty 
Designation  Post Graduate  
Affiliation  Maulana Azad Medical College 
Address  Department of Community Medicine, Maulana Azad Medical College, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi 110002
Central
DELHI
110002
India 
Phone  09990640012  
Fax    
Email  srishtyrajaura2530@gmail.com  
 
Source of Monetary or Material Support  
Department of Community Medicine, Maulana Azad Medical College, New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College  
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srishty  Maulana Azad Medical College  Department of Community Medicine, Maulana Azad Medical College, New Delhi
Central
DELHI 		 9990640012

srishtyrajaura2530@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and Associated Hospitals Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy people 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults aged 18 years and above.
Residents of Gokalpur for at least six months.
Individuals capable of providing informed consent.
participants able to read or understand Hindi or English 
 
ExclusionCriteria 
Details  Healthcare professionals or students in medical, pharmaceutical, or related fields.
Individuals unwilling or unable to provide informed consent.
Participants with significant cognitive impairments or language barriers preventing effective communication during the survey. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants demonstrating adequate knowledge and awareness of antimicrobial resistance and appropriate antibiotic use practices.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of demographics & socioeconomic factors significantly associated with higher or lower levels of knowledge & awareness of AMR.   At the end of the study (3 months) 
Prevalence of behaviors contributing to antibiotic misuse, including a) Percentage of participants engaging in self-medication with antibiotics. b) Percentage of participants failing to complete prescribed antibiotic courses.   At the end of the study (3 months) 
 
Target Sample Size   Total Sample Size="850"
Sample Size from India="850" 
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)   09/06/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shivani.idsp@gmail.com].

  6. For how long will this data be available start date provided 02-08-2025 and end date provided 02-08-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This is a community-based, cross-sectional study aimed at assessing the knowledge and awareness of antimicrobial resistance (AMR) and antibiotic use among adults residing in Gokalpuri, Delhi. A total of 850 participants aged 18 years and above will be selected through cluster and systematic random sampling using the Kish grid method for individual selection. Data will be collected via face-to-face interviews using a pre-validated WHO questionnaire. The primary outcome is the proportion of participants demonstrating adequate awareness of AMR and appropriate antibiotic use. Secondary outcomes include identifying socio-demographic factors associated with awareness and the prevalence of behaviors contributing to antibiotic misuse. Confidentiality will be maintained, and a health education session on AMR will be provided post-survey.

 
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