| CTRI Number |
CTRI/2025/10/096188 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A study of Drug Related Problems due to antibiotic use |
|
Scientific Title of Study
|
A study on the evaluation of Drug Related Problems and factors associated with antibiotic use in the General Medicine Department - A Prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fiona Francis Fernandes |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7676702257 |
| Fax |
|
| Email |
fionafernandes013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitrashree |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9900181477 |
| Fax |
|
| Email |
chaitra.shree@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitrashree |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
KARNATAKA
575018
India |
| Phone |
9900181477 |
| Fax |
|
| Email |
chaitra.shree@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University) Deralakatte, Mangaluru, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Other [Educational 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 Adithi K |
Justice K S Hegde Charitable Hospital |
Department of General Medicine, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA |
9886517329
adithibhandary@nitte.edu.in |
|
|
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: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, aged above 18 years admitted to the General Medicine department
Prescribed at least one antibiotic for a minimum duration of 48 hours
Willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Critically ill patients
Patients admitted to Intensive Care Units (ICU)
Patients who were discharged within 48 hours of admission
Patients who refuse or are unable to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will determine the proportion of the Drug Related Problems among patients prescribed with antibiotics. |
The baseline data will be collected after three days of initiation of the antibiotic therapy. The patient will be followed up at two weeks time point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will find out the factors associated with the Drug Related Problems among patients receiving antibiotics. |
The baseline data will be collected after three days of initiation of the antibiotic therapy. The patient will be followed up at two weeks time point. |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
17/11/2025 |
| 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="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
|
INTRODUCTION: All patient groups frequently experience drug-related problems when taking medications, and those associated with antibiotics have a negative impact on patient outcomes and public health. Managing these problems requires a methodical approach. DRPs can be easily identified and categorized with the aid of tools like the APS-DOC classification system. The purpose of this study is to investigate the connection between antibiotic use and drug-related issues. NEED FOR THE STUDY: This research will help us understand the need for detecting and resolving drug related problems, particularly those associated with antibiotic use. By using an appropriate classification system, our study aims to analyse the commonly occurring DRPs of an antibiotic used in our patients and various other factors that associates with the occurrence of DRPs. OBJECTIVES OF THE STUDY: To determine the proportion of the drug-related problems (DRPs) among patients prescribed with antibiotics and to find out the factors associated with the drug-related problems among patients receiving antibiotics. METHODOLOGY: Prospective observational study will be conducted for the duration of 6 months (September 2025 - February 2026) among 196 patients. Patients undergoing antibiotic therapies will be included in this study. It will be carried out in Department of General Medicine, Justice K.S Hegde Charitable Hospital, Mangaluru. Institutional ethical committee permission will be obtained before the study. STATISTICAL ANALYSIS: Quantitative variables will be expressed using mean ± standard deviation (SD), or median (IQR). Qualitative variables will be expressed as frequencies and percentages. Associations between categorical variables will be assessed using the Chi-square test or Fisher’s exact test, as appropriate. A p-value of less than 0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS software, version 29. ANTICIPATED OUTCOME: At the end of the study, we will be able to analyse the proportion of drug-related problems (DRPs) among patients receiving antibiotic therapy. Identify the most commonly occurring types of DRPs associated with antibiotic use and the factors significantly associated with the occurrence of DRPs. |