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CTRI Number  CTRI/2018/12/016732 [Registered on: 19/12/2018] Trial Registered Prospectively
Last Modified On: 18/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Questionnaire 
Study Design  Other 
Public Title of Study   Assessment of knowledge about antibiotics and their use among Doctors in India 
Scientific Title of Study   “KNOWLEDGE, ATTITUDE AND PRACTICE survey on antibacterial use and resistance” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asem Ali Ashraf 
Designation  Junior Resident 
Affiliation  Dept of Microbiology Kasturba Medical College, Manipal Academy of Higher Education, Manipal, 
Address  Dept of Microbiology Kasturba Medical College Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  asemali611@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chiranjay Mukhopadhyay 
Designation  Professor 
Affiliation  Dept of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Address  Dept of Microbiology Kasturba Medical College Manipal Academy of Higher Education Manipal
Dept of Microbiology Kasturba Medical College Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  chiranjay.m@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Asem Ali Ashraf 
Designation  Junior Resident 
Affiliation  Dept of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Address  Dept of Microbiology Kasturba Medical College Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  asemali611@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Academy of Higher Education Manipal 
 
Primary Sponsor  
Name  Chiranjay Mukhopadhyay 
Address  Dept of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education 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 
Asem Ali Ashraf  Kasturba Medical College  Dept of Microbiology,Second Floor, Basic Sciences Building, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA 
9900404600

asemali611@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Practicing Healthcare Doctors 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Practicing Healthcare Doctors 
 
ExclusionCriteria 
Details  Incomplete Responses 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   31/12/2018 
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   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
To assess the Knowledge, Attitude and Practice regarding awareness on antibiotics usage and its resistance among Indian medical healthcare practitioners, by means of a questionnaire which will be evaluated by a five-point Likert scale. Rapid usage of antibacterial agents have increased the incidences of its resistance. Medical healthcare practitioners play a pivotal role in the fight against antibacterial resistance, by means of their judicious use and by educating the general public concerning the antibiotics usage and its consequences on developing resistance. In this study, medical healthcare practitioners will be assessed about their Knowledge, Attitude and Practice concerning antibacterial resistance. Questionnaire was drafted and peer reviewed by in-house practitioners. Corresponding email contacts of medical healthcare practitioners will be obtained from medical associations. The questionnaire will then be circulated amongst the members of the association. Along with the questionnaire, a link for the participant information sheet will be provided and the concerned physician will be asked to consent for participation. Once the willingness to participate in the study will be obtained, the objectives of the respective study will be elucidated and they will be asked to complete it anonymously. Completed questionnaires will be collected before the stipulated deadline and the responses will be analyzed. They will be assured confidentiality of the identity throughout. Questionnaire used was formed on Knowledge, Attitude and Practice. It has 5 questions for Knowledge, 11 for Attitude and 7 for Practice. 
 
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