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临床试验/CTRI/2019/10/021721
CTRI/2019/10/021721尚未招募不适用

A prospective observational cohort study to determine rate of Multidrug resistance to antimicrobial drugs in paediatric neurointensive care patients

All India institute of medical sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
To determine Rate of Multidrug resistance to antimicrobial drugs

研究概览

简要总结

INTRODUCTION:The global rise in use of antibiotics has led to development of resistant bacteria and increasing costs in healthcare. 1Paediatric patients are a high risk population subgroup for acquiring Healthcare Associated infections.Our aim is To measure burden of antimicrobial resistance in paediatric neurointensive care patients.

MATERIALS &METHODS:This prospective observational cohort study will enroll all operative neurosurgical pediatric patients aged between 1-18 year admitted in neurointensive care unit during one year period after approval from institutional ethics committee. Daily monitoring of risk factors, including devices, mechanical ventilation, laboratory indices, cultures, sensitivities, length of NSICU stay, and their final outcome, either discharge or death, will be recorded.The data collection will be  done on a predesigned proforma. The specific HAI-type will be diagnosed according to clinical and laboratory criteria set by Centers for Disease Control and Prevention. Clinical samples for microbiological culture comprise of blood, urine, pus, CSF and endotracheal aspirates and will be sent once infection is suspected according to clinical criteria set by CDC.

REVIEW OF LITERATURE:In a prospective study conducted in 2016 by El-Nawawy et al the incidence of Paediatric Intensive care unit-acquired episodes in was found to be 13.63(n=36/264episodes),which was equivalent to15.6 cases/1,000 patient days.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Age:1-18 years
  • All elective and emergency intracranial and spine surgeries.

排除标准

  • Age: >18 yrs
  • Non consenting patients
  • Patients with high risk of MDRO colonisation: antibiotic exposure history (within last 3 months) presence of underlying diseases, previous surgery (within last 1 month) exposure to other MDRO colonized patients, patients transferred from other facilities known to have a high prevalence of MDRO carriage, history of recent hospital or nursing home stays.

结局指标

主要结局

To determine Rate of Multidrug resistance to antimicrobial drugs

时间窗: One year

次要结局

  • To determine organisms and risk factors leading to Multidrug resistance(One year)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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