| CTRI Number |
CTRI/2021/09/036818 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Antibiotic Induced Adverse Drug Reaction In Orthopaedic Department |
|
Scientific Title of Study
|
A Prospective Assessment of Antibiotic Induced Adverse Drug Reaction In Orthopaedic Department
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Shilpa P V |
| Designation |
M Pharm |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences Nitte (Deemed to be University) |
| Address |
Department of Pharmacy Practice
Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7034357331 |
| Fax |
|
| Email |
shilpapv1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bharath Raj K C |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences Nitte (Deemed to be University) |
| Address |
Department of Pharmacy Practice
Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9035948490 |
| Fax |
|
| Email |
bharathraj@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Nirmal Babu |
| Designation |
Assistant Professor |
| Affiliation |
Justice K S Hegde Charitable Hospital (Nitte Deemed to be University) |
| Address |
Department of Orthopaedics
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901725830 |
| Fax |
|
| Email |
drnirmalbabu@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Justice KS Hegde Charitable Hospital, Derlakatte, Manglore |
|
|
Primary Sponsor
|
| Name |
SHILPA PV |
| Address |
Department Of Pharmacy Practice, NGSM Institute Of Pharmaceutical Sciences, Derlakatte, Manglore |
| 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 |
| Ms Shilpa P V |
Justice K S Hegde Charitable Hospital, Derlakatte, Manglore |
Department of Orthopaedics
Dakshina Kannada
KARNATAKA |
7034357331
shilpapv1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee( NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M908||Osteopathy in diseases classifiedelsewhere, |
|
|
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 |
All the patients who are prescribed with Antibiotics in the Orthopaedic Department.
Age above 18years
|
|
| ExclusionCriteria |
| Details |
Patients who are critically ill
Patients who refuse to take part in the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identify and study the antibiotic induced ADR in patients.
This study will give detailed information regarding the benefits and importance of reporting the ADR.
|
single point
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will give detailed information regarding the benefits and importance of reporting the ADR.
|
Single point |
|
|
Target Sample Size
|
Total Sample Size="245"
Sample Size from India="245"
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)
|
27/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an prospective study that will be conducted to assess the antibiotic induced adverse drug reaction in orthopaedic department . In this study, I will enroll the 245 antibiotic prescribed patients who are admitted in the orthopaedic department. This study will find out how to monitor the ADR in the orthopaedic department,examine the pattern and occurrence of ADR,and the Management of ADR. I will also develop the detailed information regarding the benefits and importance of reporting the ADR. |