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CTRI Number  CTRI/2020/05/025478 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 26/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Antimicrobial resistance in community 
Scientific Title of Study   A study to assess the Knowledge, Attitude and Practice among Community Health Professionals regarding Antimicrobial Resistance and Stewardship in Udupi district of Karnataka- A pilot study 
Trial Acronym  KAP study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ninu P Mathew 
Designation  PhD Student 
Affiliation  Kasturba Medical College 
Address  Department of Microbiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9495728770  
Fax    
Email  ninupm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chiranjay Mukhopadhyay 
Designation  Associate Dean and Professor, Director , Manipal Institute of Virology 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Microbiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay.m@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ninu P Mathew 
Designation  PhD Student 
Affiliation  Kasturba Medical College 
Address  Department of Microbiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9495728770  
Fax    
Email  ninupm@gmail.com  
 
Source of Monetary or Material Support  
Self sponsored 
 
Primary Sponsor  
Name  Ninu P Mathew 
Address  PhD research Scholar Department of Microbiology KMC Manipal 
Type of Sponsor  Other [Self] 
 
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 
Ninu Mathew  Kasturba Medical College  Department of Microbiology Basic Science Building Kasturba Medical College, Manipal Udupi
Udupi
KARNATAKA 		 08202922717

ninupm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospitals Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The target population is Community health professionals like Medical doctors and pharmacists. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  There is no intervention or comparator arm since it is a cross sectional study  No intervention is given 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  General Practitioners: General Practitioners who have Minimum degree of MBBS and any higher degree of qualification working in nursing homes, Primary Health Centers, Community Health Centers, and private hospitals where no formalized organized academic structure is available for regular teaching.
Community Pharmacists: Pharmacist who have a minimum degree of D.Pharm or any higher degree of qualification working in medical stores will be enrolled.
 
 
ExclusionCriteria 
Details  Any General Practitioners, Community pharmacists who are not willing to participate in the study will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assessment of knowledge, attitude and practice regarding Anti- Microbial resistanace.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The study will help to initiate other studies in a much wider population after the results are obtained.  6 weeks  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/06/2020 
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="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not available 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study will be a cross sectional study conducted in Udupi District of Karnataka, India. The investigator will visit the participants on prior appointment. The purpose and nature of the study will be explained to the participants and participant information sheet will also be provided. Participants will be reassured that all their personal information will be kept confidential and informed consent will be obtained.  A written informed consent will be obtained from the participants after giving a detailed description of the study. The data will be collected using a self-administered semi structured questionnaire. The content of the semi structured questionnaire will be developed by reading textbooks, articles, and available guidelines and through informal discussion with the experts. Based on the suggestions from the experts suitable modifications will be done in the questionnaire and final draft content will be developed and validated with the experts of Microbiology, Public Health, Pharmacy practice, General Medicine and community medicine. This self-administered questionnaire will be used to collect the data. The data collection will be also done using an online version of the questionnaire.

 
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