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CTRI Number  CTRI/2023/12/060877 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Single Arm Study 
Public Title of Study   Awareness on proper use of antibiotics among higher secondary school students in Udupi taluk 
Scientific Title of Study   Development of a Public Health Pharmacy Model for Capacity Building on Quality Use of Antibiotics among Higher Secondary School Students in Udupi Taluk 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anisha Sheethal Gonsalves 
Designation  Student 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal 
Address  Department of Pharmacy Practice, MCOPS, MAHE, Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008506765  
Fax    
Email  anishagonsalves1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonal Sekhar M 
Designation  Associate Professor 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal 
Address  Department of Pharmacy Practice, MCOPS, MAHE, Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411338846  
Fax    
Email  sonal.sekhar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sonal Sekhar M 
Designation  Associate Professor 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal 
Address  Department of Pharmacy Practice, MCOPS, MAHE, Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411338846  
Fax    
Email  sonal.sekhar@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Pharmaceutical Sciences, Manipal 
 
Primary Sponsor  
Name  Manipal College of Pharmaceutical Sciences, Manipal 
Address  MCOPS, MAHE, Madhava Nagar Manipal-576104 
Type of Sponsor  Other [Academic 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 Sonal Sekhar M  11th and 12th grades from Government and Private schools in Udupi Taluk  Coordinated by Dr. Sonal Sekhar M,Room.No: 8 Department of Pharmacy Practice MCOPS, MAHE, Madhava Nagar Manipal-576104
Udupi
KARNATAKA 		 7411338846

sonal.sekhar@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kasturba Hospital Ethics Committee  Approved 
The Deputy Director of Pre-University (DDPU)  Approved 
The Deputy Director of Public Instruction (DDPI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School students from 11th and 12th standard 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational intervention  The Public Health Pharmacy model includes 3 phases among secondary school students. The intervention will be designed based on the local relevance and high priority areas of improvement of antibiotic use identified in phase 1. A comprehensive educational intervention will be conducted. The duration of intervention will be around 1 hour. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Higher secondary school students (11th and 12th std).
Schools located at Udupi taluk.
Those who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  Grades other than higher secondary school students. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge, attitude, and practice on antibiotic usage, pre- and post-intervention  Baseline, 1st month, 2nd month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="263"
Sample Size from India="263" 
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   Phase 4 
Date of First Enrollment (India)   05/01/2024 
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="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  

This an operational research study with a quantitative and qualitative design following a sequential approach that will be implemented in a phased manner (phase 1 to phase 4)

Phase 1: Need analysis

A situation analysis will be carried out at the secondary schools to collect the relevant data related to secondary school students’ knowledge, awareness, and practice related to antimicrobial usage. A pre-test using a pre-designed questionnaire will be conducted to collect the above-relevant information

Phase 2: Development of educational material on antimicrobial training

The main component of educational material will be core elements of antimicrobial training and the developed educational material will be tested for readability.

Phase 3: Public pharmacy-based AMT education intervention

The PHP model includes 3 phases among secondary school students. The intervention will be designed based on the local relevance and high-priority areas of improvement of antibiotic use identified in Phase 1. A comprehensive educational intervention (educational meetings, face-to-face interaction, and distribution of educational materials and videos) will be conducted.

Phase 4: Evaluation of the implemented AMT intervention                                            

Implemented PHP model-based intervention will be evaluated by re-assessment of the phase 1 study. A post-test questionnaire will be used to collect the data from the higher secondary school students.

 
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