A study on the evaluation of Drug Related Problems and factors associated with antibiotic use in the General Medicine Department - A Prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The study will determine the proportion of the Drug Related Problems among patients prescribed with antibiotics.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The study will determine the proportion of the Drug Related Problems among patients prescribed with antibiotics.
时间窗: 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.
次要结局
- 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.)
研究者
Fiona Francis Fernandes
NGSM Institute of Pharmaceutical Sciences