| CTRI Number |
CTRI/2024/01/061110 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reduction of Antibiotics Usage in a Large Hospital. |
|
Scientific Title of Study
|
Deprescribing of Antibiotics: A Prospective Cross-Sectional Study in a Tertiary Healthcare Facility. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanima Mondal |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9609551485 |
| Fax |
|
| Email |
tanima2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Sekhar M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Room number 8, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Sekhar M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Room number 8, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education |
| Address |
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka-576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Chandrashekar UK |
Kasturba Hospital |
Room no. - 8, Department of Pharmacy Practice, 4th floor, MCODS via new OPD, Kasturba Hospital
Madhav Nagar
Manipal-576104
Udupi
KARNATAKA |
9845163448
shekar.uk@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
For the first objective: Junior (including post graduates) and senior physician who deals with the patient from pulmonary, general medicine, infectious diseases, and surgery department are included.
For the second objective: In-patients who are prescribed antibiotics and within the age limit of 18 to 80 years are included in the study.
|
|
| ExclusionCriteria |
| Details |
For the first objective: Incomplete questionnaire.
For the second objective: Incomplete medication chart.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceptions of the physician on the antibiotic deprescribing will be assessed using validated questionnaire.
To measure factors influencing antibiotic deprescribing.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="464"
Sample Size from India="464"
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)
|
10/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To study the physicians’ perceptions and other factors that influence the deprescribing of antibiotics and develop a prediction model for the deprescribing of antibiotics in a hospital setting. Objectives: 1. To assess the perceptions of antibiotic deprescribing among physicians’. 2. To determine the various factors that influence the deprescribing of antibiotics in a hospital setting. 3. To develop a prediction model for antibiotic deprescribing. Introduction: Antimicrobial resistance is frequently caused by the irrational use of antibiotics. At both the community and individual levels, there is strong evidence linking misuse of antibiotics to antimicrobial resistance; longer-term antibiotic exposure causes greater antimicrobial resistance than shorter-term exposure. Reducing the use of antibiotics requires the right mechanism at the right time. Various methods have been developed to decrease the improper use of antibiotics. Deprescribing, a planned method of medication withdrawal, is quickly gaining popularity around the globe. Non-adherence, polypharmacy, risk of adverse drug reactions and usage of potentially inappropriate medicines can be brought down by antibiotic deprescribing. Therefore, antibiotic deprescribing is crucial for improving patient outcomes, reducing unnecessary adverse effects, and maximizing cost-benefit. Need of the study: There is not much research on antibiotic deprescribing, especially in India, carrying out this study will be beneficial to all medical professionals and patients. The purpose of this study is to evaluate the factors that influence the deprescribing of antibiotics in healthcare settings and the perception of physicians regarding this practice and ultimately develop a prediction model for antibiotic deprescribing. Methodology: This will be a prospective cross-sectional study which will involve the assessment of physicians’ perception about antibiotic deprescribing through a questionnaire and to know their general perception regarding antibiotic deprescribing through qualitative interviews. Patients who are prescribed antibiotics, their medication chart will be assessed after obtaining consent from them. Patient will be interviewed to collect their medical and medication history after their consent. Participant information sheet and informed consent form will be given to respective patients. A pre-designed data collection form will be used to collect the data. Lastly, a prediction model will be developed for antibiotic deprescribing.
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