| CTRI Number |
CTRI/2025/10/096151 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of Antibiotics Among Urinary Tract Infection Patients |
|
Scientific Title of Study
|
Assessment Of Prescription Pattern Of Antibiotics Based On WHO AWaRe Classification Among Urinary Tract Infection Patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samprus Jude Almeida |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Dept. Of Pharmacy Practise, NGSM Institute Of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7022590075 |
| Fax |
|
| Email |
samprusjude@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Dept. Of Pharmacy Practise, NGSM Institute Of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Dept. Of Pharmacy Practise, NGSM Institute Of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University) Deralakatte, Mangalore, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE Deemed to be University NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru, 575018, Karnataka, India |
| 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 Rajeev Thekke Puthalath |
Justice K S Hegde Charitable Hospital |
Dept. Of Urology, Third Floor, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA |
9986451908
rajeevtp@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: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or older, with or without comorbidity. |
|
| ExclusionCriteria |
| Details |
Patients with missing information such as culture and sensitivity reports. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help in identification and categorization of antibiotics as per the WHO AWaRe classification. |
At baseline and after culture sensitivity test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will provide an overview of antibiotic prescription pattern, and resistance pattern. |
One year |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
01/11/2025 |
| 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 UTIs are inflammatory reactions of the urinary tract, mainly caused by multispecies microorganisms. Patients with UTIs typically experience symptoms such as frequent urination, burning micturition, flank pain, foul-smelling urine and haematuria. Treating UTI with antibiotics inappropriately or the overuse of antibiotics will lead to antimicrobial resistance (AMR). To prevent an increase in the AMR rates, the World Health Organisation (WHO) introduced the A WaRe classification to promote rational use of antibiotics globally.
OBJECTIVES This study aims to assess the prescription pattern of antibiotics among urinary tract infection patients and to categorize the empirical and definitive antibiotic therapy based on the WHO AWaRe (Access, watch and Reserve) classification.
METHODOLOGY This retrospective study will be conducted at Justice K.S Hegde Charitable Hospital, Deralakatte Mangaluru, India. The sample size is calculated to be approximately 600 patients. Ethical approval will be obtained by the institution’s ethics committee (IEC) before the commencement of the study. The duration of the study will be six months and the patients will be selected based on the inclusion and exclusion criteria.
STATISTICAL ANALYSIS Descriptive data will be expressed as frequency and percentages. Quantitative data will be expressed as mean ± standard deviation or median (IQR). Chi-square test/fisher exact test will be used to find association between categorical variables. P-value less than 0.05 will be considered significant. Statistical Package for Social Sciences (SPSS) software version 29 will be used for data analysis.
ANTICIPATED OUTCOME The study will provide an overview of antibiotic prescription pattern and it will help in identification and categorization of antibiotics as per the WHO AWaRe classification. |