| 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
|
|
|
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
|
|
|
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. |