| CTRI Number |
CTRI/2026/04/107401 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of How Antibiotics Are Prescribed to Orthopaedic Patients |
|
Scientific Title of Study
|
An Observational Study on Antibiotic Prescription Pattern Using WHO AWaRe
(Access, Watch, and Reserve) Guideline Among Patients Visiting the Department of Orthopaedics at SMS Medical College and Attached Hospitals, Jaipur, Rajasthan. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Kumar Serawat |
| Designation |
Junior resident |
| Affiliation |
SMS medical college and hospital jaipur |
| Address |
Department of pharmacology SMS medical college JLN marg jaipur 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
7878837791 |
| Fax |
|
| Email |
mserawat70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uma Advani |
| Designation |
Professor |
| Affiliation |
SMS medical college and hospital jaipur |
| Address |
Department of pharmacology SMS medical college JLN marg jaipur 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413510355 |
| Fax |
|
| Email |
drupadvani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uma Advani |
| Designation |
Professor |
| Affiliation |
SMS medical college and hospital jaipur |
| Address |
Department of pharmacology SMS medical college JLN marg jaipur 302004
RAJASTHAN
302004
India |
| Phone |
9413510355 |
| Fax |
|
| Email |
drupadvani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS medical college and hospitals |
| Address |
SMS medical college JLN marg jaipur 302004 |
| Type of Sponsor |
Government 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 |
| Dr Manish Kumar Serawat |
SMS medical college and hospital |
Room number 11 department of orthopaedics JLN marg jaipur 302004
Jaipur
RAJASTHAN |
7878837791
mserawat70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee S.M.S. Medical College and Attached Hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M860||Acute hematogenous osteomyelitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving written informed consent
Patients visiting Department of Orthopaedics who are Prescribed with Anti-Microbial Drug. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Average number of drugs prescription.
2. Percentage of drugs prescribed with the generic name.
3. Percentage of prescription with Anti-Microbial agents.
4. Percentage of prescription with injections.
5. Percentage of antibiotics classified according to AWaRe guidelines. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of encounters with self medication
Percentage of encounters with drug drug interaction
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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)
|
15/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Our study will provide valuable insight into the antibiotic prescription patterns among
Orthopaedics OPD patients using WHO core prescribing indicators and the AWaRe
(Access, Watch, and Reserve) guideline, to identify potential areas for improvement in
rational antibiotic use, as limited studies have been published on this topic. |