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CTRI Number  CTRI/2019/06/019518 [Registered on: 04/06/2019] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Factors determining usage of medicines by patients, nurses and doctors. 
Scientific Title of Study   Determinants of antibiotic use/misuse from patient’s and health providers’ perspective- A descriptive analysis from coastal karnataka 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhika jain 
Designation  3rd year mbbs student 
Affiliation  Kasturba Medical College, Manipal, Karnataka 
Address  Kasturba medical college, Manipal, karnataka, Department of community medicine.

Udupi
KARNATAKA
576104
India 
Phone  7022885405  
Fax    
Email  shubhikajn24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chythra R Rao 
Designation  MD community medicine 
Affiliation  Kasturba Medical College, Manipal 
Address  Kasturba medical college, manipal,Department of community medicine, karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9448857793  
Fax    
Email  chythra.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Chythra R Rao 
Designation  MD community medicine 
Affiliation  Kasturba Medical College, Manipal 
Address  Kasturba medical college, manipal,Department of community medicine, karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9448857793  
Fax    
Email  chythra.raj@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college, Manipal academy of higher education,Manipal, karnataka, 576104 
 
Primary Sponsor  
Name  Kasturba medical college Manipal karnataka 
Address  Kasturba medical college, Madhav nagar, Manipal, karnataka 
Type of Sponsor  Private medical college 
 
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 Chythra R Rao  Kasturba medical college and kasturba hospital  Madhav nagar, Manipal academy of higher education, Department of community medicine, 3rd floor, room no. 6, manipal, karnataka, 576104
Udupi
KARNATAKA 		 9448857793

chythra.raj@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Commiittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  people visiting a tertiary health care centre and health care workers working in tertiary health care centre 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Available and consenting.  
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess awareness and practices pertaining to antibiotic use.
Assess perception about antibiotic use among health care providers. 		 After 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="434"
Sample Size from India="434" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="434" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/06/2019 
Date of Study Completion (India) 10/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The attempt of this study is to consolidate perceptions of different stakeholders and outline the present knowledge, attitude and practice lags with respect to antibiotic use and misuse. The emerging antimicrobial resistance is not only consumer’s (patient’s) responsibility, but is an integrated result of behavior and practices of healthcare providers as well. Growing pattern of antibiotic misuse (sub optimal duration and frequency) and abuse (non-indicated conditions like headache, abdominal pain) can be outlined unbiasedly only when all the factors influencing the patient’s choice and source of antibiotics are considered.  Thus, assessing the perceptions of providers and consumers is indispensable for effective planning and implementation of awareness generation and antimicrobial stewardship programs.  Assessment of patients’ awareness regarding proper antibiotic usage and ascertaining the perceptions of various stakeholders in the hospital setting like physicians and nurses who directly or indirectly influence the patient’s compliance to antibiotics becomes vital. With this background in mind, we intend to interview patients, physicians and nurses in a teaching hospital to identify the factors that drives the use and misuse of antibiotics.  
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