| CTRI Number |
CTRI/2024/10/074772 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining the Prescriptions in pharmacy that are according to WHO Access, Watch and Reserve (AWaRe) classification. |
|
Scientific Title of Study
|
Evaluation of Antibiotic Prescription Patterns in a Community Pharmacy based on WHO Access, Watch and Reserve (AWaRe) classification |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreedharan Nair |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
8660930119 |
| Fax |
|
| Email |
nair.sreedhar@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Alahari Punith Krishna |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9390544289 |
| Fax |
|
| Email |
alahari.mcopsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sreedharan Nair |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
8660930119 |
| Fax |
|
| Email |
nair.sreedhar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Radha Medicals
1st Floor, Raja Tower Building, Bus Stand Road, Udupi, Karnataka.
576101 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Udupi
KARNATAKA
576104
India |
| 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 Sreedharan Nair |
Kasturba Hospital, Manipal |
Department of Pharmacy Practice, 4th floor, MCODS, via New OPD block, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104.
Udupi
KARNATAKA |
8660930119
nair.sreedhar@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 |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
✓ All antibiotics prescriptions dispensed during the study period are included.
✓ Prescriptions with complete set of data that includes patient age, gender, strength, dose, duration and name of antibiotic prescribed |
|
| ExclusionCriteria |
| Details |
✓Over-the-counter antibiotic purchase without a prescription
✓Incomplete prescriptions.
✓ Prescriptions of patient who deny to provide consent. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness of the usage of antibiotics in the community pharmacy. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="634"
Sample Size from India="634"
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)
|
14/10/2024 |
| 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="10"
Days="25" |
|
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
|
Antimicrobial resistance (AMR) is a serious worldwide problem that threatens the foundations of modern medicine and can result in increased morbidity and mortality. Hence to address this problem and to guide appropriate antibiotic prescribing, the World Health Organization (WHO) Access, Watch, Reserve (AWaRe) classification system was introduced. Therefore, evaluating the antibiotics prescription patterns in community pharmacies based on WHO AWaRe classification helps us to understand whether the antibiotics with higher resistance potential (Watch and Reserve groups) are prescribed judiciously. |