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CTRI Number  CTRI/2025/08/092737 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Improving Knowledge regarding Antimicrobial Resistance through Education 
Scientific Title of Study   Assessing the Impact of a Structured Pharmacy Education Program on Knowledge, Understanding, and Role of Pharmacists in Antimicrobial Stewardship 
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 Vandana K E 
Designation  Professor 
Affiliation  Department of Microbiology, Kasturba Medical College, Manipal 
Address  Room no. 4, Faculty rooms, Department of Microbiology, 2nd floor, Basic Science Building Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902206009  
Fax    
Email  vandana.ke@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana K E 
Designation  Professor 
Affiliation  Department of Microbiology, Kasturba Medical College, Manipal 
Address  Room no. 4, Faculty rooms, Department of Microbiology 2nd floor, Basic Science Building Kasturba Medical College, Manipal


KARNATAKA
576104
India 
Phone  9902206009  
Fax    
Email  vandana.ke@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vandana K E 
Designation  Professor 
Affiliation  Department of Microbiology, Kasturba Medical College, Manipal 
Address  Room no 4, Faculty rooms, Department of Microbiology, 2nd floor, Basic Science Building Kasturba Medical College, Manipal


KARNATAKA
576104
India 
Phone  9902206009  
Fax    
Email  vandana.ke@manipal.edu  
 
Source of Monetary or Material Support  
Centre for Antimicrobial Resistance and Education (CARE), Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India -576104 
 
Primary Sponsor  
Name  Centre for Antimicrobial Resistance and Education CARE 
Address  Room no 13, KMC faculty rooms Kasturba Medical College Manipal Academy of Higher Edcucation, Manipal, Udupi, Karnataka, India - 576104 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Vandana K E  Kasturba Medical College  Department of microbiology, 2nd floor, Basic Science Building, Madhav Nagar, Manipal -576104
Udupi
KARNATAKA 		 9902206009

vandana.ke@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants of the certificate course Antimicrobial Stewardship: From classroom to bedside by Manipal Academy of Higher Education 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Education modules and bed side training  Live online lectures through MS Teams covering clinical microbiology, pharmacology, infectious diseases, antimicrobial and diagnostic stewardship, clinical pharmacy, and ethics/leadership; each lecture will be followed by an interactive quiz delivered, or short gamified exercises to reinforce key concepts. At the end of the program, a week of hands-on bedside training at Kasturba Hospital will immerse participants in real-time antimicrobial stewardship rounds, case discussions, and prescription reviews under the mentorship of clinical microbiologists, infectious disease physicians,, and clinical pharmacists. Participants will also complete a research assignment immediately upon course completion 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants of the certificate course Antimicrobial Stewardship: From classroom to bedside 
 
ExclusionCriteria 
Details  Participants who are not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in AMS knowledge and understanding scores at baseline and after intervention
Perceived role and confidence in AMS practices

Retention of learning outcomes after 6 months

Emergent themes from interviews on the application of AMS concepts 		 Before, after and 6 months after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/09/2025 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [vandana.ke@manipal.edu].

  6. For how long will this data be available start date provided 30-09-2025 and end date provided 30-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study will commence after obtaining the ethical clearance from the Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital, Manipal and CTRI approval. The participants who meet the eligibility criteria will receive an information sheet and written informed consent. The quantitative online questionnaire will be sent to the participants to collect data. A separate description regarding voluntary participation will be added to the form. Over the next 4 months, the structured AMS education program will be conducted in sequential modules: on the second and fourth Saturdays of each month, participants will join 4:00–8:00 PM IST live online lectures through MS Teams covering clinical microbiology, pharmacology, infectious diseases, antimicrobial and diagnostic stewardship, clinical pharmacy, and ethics/leadership; each lecture will be followed by an interactive quiz delivered, or short gamified exercises to reinforce key concepts. At the end of the program, a week of hands-on bedside training at Kasturba Hospital will immerse participants in real-time antimicrobial stewardship rounds, case discussions, and prescription reviews under the mentorship of clinical microbiologists, infectious disease physicians,, and clinical pharmacists. Participants will also complete a research assignment immediately upon course completion. An online post-test identical in structure to the baseline questionnaire will be administered, and follow-up interviews will be scheduled within two weeks to qualitatively assess immediate learning and barriers to application. Six months after the final lecture, participants will again receive the same questionnaire via email with two reminder prompts at one- and two-week intervals, followed by a final round of MS Teams interviews to evaluate knowledge retention, sustained changes in practice, and perceived impact on their AMS role. Throughout the study, all data will be timestamped, anonymized, and stored on secure institutional and interview transcripts maintained in encrypted files. 
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