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Clinical Trials/CTRI/2025/10/096151
CTRI/2025/10/096151
Not yet recruiting
Not Applicable

Assessment Of Prescription Pattern Of Antibiotics Based On WHO AWaRe Classification Among Urinary Tract Infection Patients

NITTE Deemed to be University NGSM Institute of Pharmaceutical Sciences1 site in 1 country600 target enrollmentStarted: November 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
NITTE Deemed to be University NGSM Institute of Pharmaceutical Sciences
Enrollment
600
Locations
1
Primary Endpoint
The study will help in identification and categorization of antibiotics as per the WHO AWaRe classification.

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 18 years or older, with or without comorbidity.

Exclusion Criteria

  • Patients with missing information such as culture and sensitivity reports.

Outcomes

Primary Outcomes

The study will help in identification and categorization of antibiotics as per the WHO AWaRe classification.

Time Frame: At baseline and after culture sensitivity test.

Secondary Outcomes

  • The study will provide an overview of antibiotic prescription pattern, and resistance pattern.(One year)

Investigators

Sponsor
NITTE Deemed to be University NGSM Institute of Pharmaceutical Sciences
Sponsor Class
Other [Educational Institution]
Responsible Party
Principal Investigator
Principal Investigator

Samprus Jude Almeida

NGSM Institute of Pharmaceutical Sciences

Study Sites (1)

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