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CTRI Number  CTRI/2019/10/021573 [Registered on: 09/10/2019] Trial Registered Prospectively
Last Modified On: 06/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To check Respiratory Tract infected Patients Knowledge, Attitude and Practice on Antibiotic Usage in a Tertiary Care Hospital. 
Scientific Title of Study   Assessment Of Knowledge, Attitude And Practice Regarding Antibiotic Use In Patients Suffering From Respiratory Tract Infection In A Tertiary Care Hospital. 
Trial Acronym  KAPARTI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep A 
Designation  M.Pharm Student 
Affiliation  Nitte Deemed to Be University 
Address  NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru.

Kasaragod
KERALA
671317
India 
Phone  9539196770  
Fax    
Email  Sandeepa906@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajesh K S 
Designation  Asst. Professor 
Affiliation  Nitte Deemed to Be University 
Address  NGSMIPS, Nitte Deemed to be University, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8050347455  
Fax    
Email  rajeshks@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Sandeep A 
Designation  M. Pharm Student 
Affiliation  Nitte Deemed to Be University 
Address  New House Benoor, (P.O) Perumbala, ( Via) Kalanad, Kasrgod, 671317, Kerala

Kasaragod
KERALA
671317
India 
Phone  9539196770  
Fax    
Email  Sandeepa906@gmail.com  
 
Source of Monetary or Material Support  
Justice K.S Hegde Charitable Hospital, Deralakatte, Mangulru 
 
Primary Sponsor  
Name  Sandeep A  
Address  New House Benoor, (P.O) Perumbala, (via) Kalanad, Kasargod, Kerala. 
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 
Sandeep A  Justice K S Hegde Charitable hospital Deralakatte Mangaluru  Room no: 7, Dept. of Pulmonary Medicine.
Dakshina Kannada
KARNATAKA 
9539196770

Sandeepa906@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NGSM Institute of Pharmaceutical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ANTIBIOTICS  ALL RESPIRATORY TRACT INFECTION RELATED ANTIBIOTICS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. All patients with respiratory tract infection who are prescribed with at least one antibiotic in Pulmonary Medicine out patient department.
2. Either gender
3. Age above 18 years
 
 
ExclusionCriteria 
Details  1. Patients who are not willing to participate in the study.
2. Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The study will give the detailed information regarding antibiotic use in patients suffering from respiratory tract infection.
Based on this study results, further studies can be performed and to create awareness programs about antibiotic resistance and ensure rational use of antibiotics from the initial stage of clinical practice.
 
8 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
The study will give the detailed information regarding antibiotic use in patients suffering from respiratory tract infection.
Based on this study results, further studies can be performed and to create awareness programs about antibiotic resistance and ensure rational use of antibiotics from the initial stage of clinical practice.
 
8 MONTHS 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   14/10/2019 
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="7"
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  

ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE REGARDING ANTIBIOTIC USE IN PATIENTS SUFFERING FROM RESPIRATORY TRACT INFECTION IN A TERTIARY CARE HOSPITAL

BRIEF DESCRIPTION OF THE PROPOSAL

INTRODUCTION: Antibiotics are agents used to prevent and treat bacterial infections. They are the most commonly used drug class in the developing countries. Now a day’s resistance to antimicrobial drugs by the microorganism is increased due to improper use of antibiotics. Due to high infectious disease in country, antibiotics are the most frequently prescribed drugs, which results in increased antimicrobial resistance (AMR). There are many evidences to say that there is a relationship between antibiotic misuse and increasing bacterial resistance. In developing countries respiratory tract infections are major cause of increased length of hospital stay, morbidity and mortality due to inappropriate use of antibiotics.  AIMS AND OBJECTIVES: To design and validate the knowledge, attitude and practice questionnaire regarding antibiotic use in patients suffering from respiratory tract infection. To assess the knowledge, attitude and practice regarding antibiotic use in patients suffering from respiratory tract infection by using validated questionnaire.  JUSTIFICATION FOR THE STUDY: Recently, researchers have focused their attention on antibiotic misuse, and follow with interest the knowledge, attitude and practice (KAP) towards the antibiotic use of public. There are studies focused on public views on irrational antibiotic usage and their result showed that by educating public on antibiotic usage, the antibiotic resistance could be reduced. Hence my study is to assess the knowledge attitude and practice of antibiotic use among patient suffering from respiratory tract infection and to create awareness about antibiotic resistance and ensure rational use of antibiotics from the early stage of clinical practice. METHODOLOGY: Prospective observational study will be conducted for an 8-month duration. All patients of either gender aged above 18 years with respiratory tract infection who are prescribed with at least one antibiotic in Pulmonary Medicine department are included in study. Patients who are not willing to participate in the study and pregnant women are excluded from the study. The knowledge, attitude and practice questionnaire will be developed by referring primary, secondary and tertiary resources. Questionnaire will be validated by content and face validation method. Patient will be selected by random sampling method. Patient demographic parameters such as age, sex, educational qualification, occupation details etc will be recorded. Patient will be enrolled and interviewed by using KAP questionnaire and the scores will be documented.  STATISTICAL ANALYSIS: Qualitative data will be summarized by using frequency, percentage. Quantitative variable will be documented by using mean, standard deviation, and confidence interval. Statistical software will be used to analyze the collected data.  OUTCOME MEASURE AND WHETHER IT IS OF NATIONALE SIGNIFICANCE WITH RATIONALE: The study will give the detailed information regarding antibiotic use in patients suffering from respiratory tract infection. Based on this study report, if needed further interventional studies can be done in future and to create awareness about antibiotic resistance and ensure rational use of antibiotics from the initial stage of clinical practice.


 
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