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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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