| CTRI Number |
CTRI/2025/03/082868 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study observing on Antimicrobial Prescribing Pattern in Out-patient of General Medicine Department at SMS Hospital, Jaipur. |
|
Scientific Title of Study
|
A Descriptive Observational Study on Antimicrobial Prescribing Pattern in Out-patient of General Medicine Department using WHO Prescribing Indicators and AWaRe Assessment Tool at SMS Hospital, Jaipur. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHITA MALI |
| Designation |
Postgraduate Resident |
| Affiliation |
Sawai Man Singh Medical College. |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
75691000754 |
| Fax |
|
| Email |
harshitamali141@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Jain |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College. |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828786533 |
| Fax |
|
| Email |
monicajain07@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Jain |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College. |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828786533 |
| Fax |
|
| Email |
monicajain07@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College And Attached Hospital Jaipur Rajasthan, India. 302004 |
|
|
Primary Sponsor
|
| Name |
HARSHITA MALI |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
|
| 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 |
| Dr Harshita Mali |
SMS Hospital, Jaipur |
Room no. 1 , Outpatient Department of General Medicine.
Jaipur
RAJASTHAN |
7691000754
harshitamali141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee, SMS Medical College and Attached Hospital, Jaipur. |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient attending outdoor of General medicine department and who has been prescribed at least 1 antimicrobial.
Patients who willingly give informed consent.
|
|
| ExclusionCriteria |
| Details |
Non-cooperative patients.
Severely ill patients.
Follow up cases who has been prescribed antimicrobial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the antimicrobial prescribing patterns in Out-door of General medicine department using
i) WHO prescribing indicators and
ii) AWaRe assessment tool by WHO
2. To categories the prescribed antimicrobial according to AWaRe criteria.
3. To describe the proportion of various antimicrobial used.
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="630"
Sample Size from India="630"
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)
|
15/04/2025 |
| 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
|
Worldwide there is increasing concern about antimicrobial drugs
losing their effectiveness, with resistance increasing across all categories,
from first-line antimicrobial to last-resort options. This persistent rise in
antimicrobial resistance (AMR) has emerged as a significant public health
problem, exacerbated by the slow development of new antibiotic classes and
decreasing investments in novel antimicrobial drugs1.
|