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临床试验/CTRI/2025/10/096151
CTRI/2025/10/096151尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
试验地点
1
主要终点
The study will help in identification and categorization of antibiotics as per the WHO AWaRe classification.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: At baseline and after culture sensitivity test.

次要结局

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

研究者

发起方
NITTE Deemed to be University NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Educational Institution]
责任方
Principal Investigator
主要研究者

Samprus Jude Almeida

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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