| CTRI Number |
CTRI/2021/02/030883 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge, Attitude and Practices of pharmacists working in medical shops towards promoting appropriate use of antibiotics (medicines for bacterial infection) and other antimicrobials (medicines for viral, fungal, parasitic infections) in Mumbai |
|
Scientific Title of Study
|
Knowledge, Attitude and Practices of Community Pharmacists towards
antimicrobial stewardship, in Mumbai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreya Abraham |
| Designation |
Post Graduation Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health,
Madhav Nagar, Manipal, Karnataka, 576104.
Udupi
India
Udupi
KARNATAKA
576104
India |
| Phone |
9843723714 |
| Fax |
|
| Email |
sreyaa95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
First floor, Prasanna School of Public Health,
Madhav Nagar, Manipal, Karnataka, 576104.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9538126121 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sreya Abraham |
| Designation |
Post Graduation Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health,
Madhav Nagar, Manipal, Karnataka, 576104.
Udupi
India
Udupi
KARNATAKA
576104
India |
| Phone |
09843723714 |
| Fax |
|
| Email |
sreyaa95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health |
| Address |
Address Room number 63, Prasanna School of Public Health, Madhav Nagar,
Manipal, Karnataka, 576104.
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sumit Kumar |
Prasanna School of Public Health, Manipal |
LH- 63, First Floor,
Prasanna School of
Public Health, Manipal
Udupi
KARNATAKA
Udupi
KARNATAKA |
8867620088
kumar.sumit@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pharmacists who work in a licensed medical store established in Mumbai with a minimum of 1-year experience working in the field.
|
|
| ExclusionCriteria |
| Details |
Personnel working in medical shops having no formal training i.e. degree or diploma in pharmaceutical sciences will be excluded from the study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will assess the Community Pharmacists’ knowledge regarding
antibiotic usage and their attitude and practices towards antimicrobial stewardship, and the
correlation of the outcomes with demographic variables. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To consider the results and help develop training modules and workshops to enhance the knowledge and practices of community pharmacists towards antimicrobial stewardship. |
6 months to 1 year |
|
|
Target Sample Size
|
Total Sample Size="417"
Sample Size from India="417"
Final Enrollment numbers achieved (Total)= "417"
Final Enrollment numbers achieved (India)="417" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2021 |
| Date of Study Completion (India) |
04/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional study to assess the knowledge, attitude and practices of community pharmacists towards antimicrobial stewardship. The study will be conducted in urban areas of Mumbai on 417 community pharmacists working in licensed medical stores. The primary outcome will be to study the community pharmacists’ knowledge regarding antibiotic usage and their attitude and practices towards antimicrobial stewardship, and the correlation of the outcomes with demographic variables. . The secondary outcome will be to consider these results and help develop policies and training modules to enhance the knowledge and practices of community pharmacists towards antimicrobial stewardship. |