| CTRI Number |
CTRI/2025/10/096743 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Study of Antibiotic-Linked Drug Issues in Hospitals |
|
Scientific Title of Study
|
Assessment of Antibiotic-Associated Drug Related Problems in Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandrika Bhaskar Pawar |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9699825204 |
| Fax |
|
| Email |
chandrika.pawar@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Salim K T |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9656798071 |
| Fax |
|
| Email |
salim.kt@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivashankar K N |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Medicine, Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital Udupi- Hebri Rd, Madhav Nagar, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Udupi- Hebri Rd, 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 |
| Dr Shivashankar K N |
Kasturba Medical College and Hospital |
Department of Medicine
Udupi- Hebri Rd, Madhav Nagar, Manipal, Karnataka, 576104
Udupi
KARNATAKA |
9448623861
shi.sha@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 - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above
Hospital Stay of 24 hours or more
Patients on Antibiotics Admitted to the Medicine Ward
|
|
| ExclusionCriteria |
| Details |
Incomplete Medical Records
Patients Not Giving Consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify and assess the Drug-Related Problems that may arise in patients |
At baseline, 4 weeks after baseline, 8 weeks after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to identify the incidence, frequency, & severity of drug-related Problems due to antibiotic. |
At baseline, 4 weeks after baseline, 8 weeks after baseline |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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)
|
03/11/2025 |
| 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="1"
Months="0"
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
|
This is a prospective longitudinal study that aims to identify and assess the Drug-Related Problems that may arise in patients receiving Antibiotic therapy. The study specifically focuses on patients taking antibiotics who are admitted to the medicine ward for more than 24 hours in the hospital. Various tools such as PCNE classification, Naranjo’s Algorithm for Causality Assessment and Hartwigs Severity assessment scale will be used asses the outcomes. Additionally SPSS 20.0 software and criteria for determining the preventability of ADR will be used too. The findings from this study will help in further understanding the frequency, severity, and analysis of DRPs caused due to antibiotics.
|