| CTRI Number |
CTRI/2025/03/081880 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Other |
|
Public Title of Study
|
Empowering Pharmacists To Fight Antibiotic Resistance |
|
Scientific Title of Study
|
Impact of Educational Interventions on Community Pharmacists Knowledge, Attitude and Practice on Antibiotic dispensing in the state of Kerala |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANSU SARAH KORUTHU |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
ASSISTANT PROFESSOR
DEPARTMENT OF PHARMACY PRACTICE
MAR DIOSCORUS COLLEGE OF PHARMACY
SREEKARIYAM, TRIVANDRUM-17, KERALA STATE Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
ansu.mcopsmpl2022@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sonal Sekhar |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy PRactice
College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Preeja G Pillai |
| Designation |
Professor |
| Affiliation |
Mar Dioscorus College of Pharmacy |
| Address |
Principal
Mar Dioscorus College of Pharmacy
Hermongiri Vidyapeetam, Alathara
Sreekariyam
Thiruvananthapuram KERALA 695017 India |
| Phone |
9495535026 |
| Fax |
|
| Email |
preejagpillai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mar Dioscorus College of Pharmacy |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ansu Sarah Koruthu |
Mar Dioscorus College of Pharmacy |
Department of Pharmacy Practice
Hermongiri Vidyapeetom
Alathara
Sreekariyam Thiruvananthapuram KERALA |
9447326665
ansu.mcopsmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAR DIOSCORUS COLLEGE OF PHARMACY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
KAP studying |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
educational |
6 MONTHS
ANTIMICROBIAL STEWARDSHIP FOR COMMUNITY PHARMACY PERSONNEL
This free electronic learning module explores the effects of antimicrobial resistance and highlights the crucial role that community pharmacy staff can play in combating it. The program aims to:
• Clarify the Link: Explain how antibiotic use contributes to the development of antibiotic resistance.
• Define Roles: Help pharmacy staff identify their responsibilities in optimizing antibiotic use among the patients who visit their pharmacies.
• Enhance Advising Skills: Improve the provision of self-care and safety-netting advice by utilizing specific Antimicrobial Stewardship Program (AMSP) tools.
• Increase Awareness: Raise awareness of the global implications of AMR.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants must be registered with the Kerala Pharmacy Council and hold one of the following qualifications: D Pharm, B Pharm, M Pharm or Pharm D
2. Participants must be employed as either full-time or part-time allopathic community pharmaciss within Kerala State |
|
| ExclusionCriteria |
| Details |
1. Other individuals in the pharmacy field, including trainees or sales personnel, who do not possess a pharmacy degree.
2. Those pharmacists 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 |
Educate the pharmacists regarding dispensing practice of antimicrobials
Improve the rational use of antibiotics among public |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved health care outcomes related to antibiotic use |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="410" Sample Size from India="410"
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)
|
17/03/2025 |
| 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="0" 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 - NO
|
|
Brief Summary
|
The rise in antibiotic use presents a significant problem because their improper use can result in antibiotic resistance. Community pharmacies frequently provide antibiotics without requiring a prescription. The study intends to explore how community pharmacists currently perceive and manage antimicrobial use, assessing their understanding of stewardship principles, attitudes towards antimicrobial resistance and daily practices related to dispensing and counselling on antibiotics |