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临床试验/CTRI/2024/07/071126
CTRI/2024/07/071126尚未招募不适用

Antibiotic Consumption And Its Susceptibility Pattern In Neonates: A Retrospective Study

未提供1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2024年8月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
384
试验地点
1
主要终点
To Calculate Antimicrobial Consumption using AMC Tool

研究概览

简要总结

INTRODUCTION

The neonatal period is the first 4 weeks of a child’s life. Neonates are most susceptible to infectious agents due to the low immune system. Neonatal sepsis is one of the most common causes of neonatal mortality and morbidity. Antibiotics are the commonest drugs used in the NICU. Virtually all extremely low birth weight infants receive antibiotics and for all other birth weight groups admitted to the NICU, majority are treated with antibiotics AMC Tool computes antimicrobial consumption data provided as numbers of packages into numbers of DDD using the ATC/DDD index.

OBJECTIVE

To calculate antimicrobial consumption using AMC (antimicrobial consumption) tool

To analyze the antibiotic susceptibility patterns among neonates.

JUSTIFICATION OF THE STUDY

There is an increase in antibiotic resistance because of the improper culture sensitivity test and if the culture sensitivity test is not done properly there will be an impact on neonates which might lead to the failure of treatment, morbidity mortality. AMC tool will help to evaluate the consumption and resistance pattern in neonates in an effective way. In developing nations, bloodstream infections are a leading cause of illness in paediatric patients. However, there is an increase in both the amount of antimicrobial medication resistance and the appearance of causative agents.

METHODOLOGY

A retrospective study in neonates who had consumed antibiotics and who have attended the inpatient units in paediatrics for the last 3 years at Justice K.S Hedge charitable hospital in age group less than 1 month along with their culture sensitivity report will be enrolled in the study. A structured data collection form using AMC tool was used to collect data. Based on inclusion criteria Neonates <1 month of age who have been admitted in NICU for the following diagnosis such as Suspected neonatal sepsis, Proven or confirmed neonatal sepsis, Pneumonia, Meningitis, Necrotizing enterocolitis, Surgical site infection, Osteomyelitis, Septic arthritis, Umbilical sepsis, along with their clear information and response to antibiotic therapy will be incorporated into the study

STATISTICAL ANALYSIS

The data will be entered in Ms excel and analysed using SPSS [V29.0]. The quantitative data will be expressed as mean ± SD and qualitative data using frequency [%]. Data will also be represented graphs or diagrams.

OUTCOME MEASURES

This study will give overview of bacteriological profile, resistance pattern, sensitivity pattern in neonate patients and choice of empirical antibiotic therapy initiated in neonates.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • Participants less than 1 month of age who have been admitted in NICU for the following diagnosis, receiving IV antibiotics for a minimum of 5 days Suspected neonatal sepsis Proven or confirmed neonatal sepsis Pneumonia Meningitis Necrotizing enterocolitis Surgical site infection Osteomyelitis Septic arthritis Umbilical sepsis All participants who were treated in the last 2 years (2020- 2021)in Justice KS Hedge Hospital.
  • Participants with clear information and response to antibiotic therapy will be incorporated into the study.

排除标准

  • Participants who were discharged against medical advice.

结局指标

主要结局

To Calculate Antimicrobial Consumption using AMC Tool

时间窗: 8 Months

次要结局

  • Choice of empirical antibiotic therapy initiated in participants(8 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Wiona Denita Moras

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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