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临床试验/NCT00621803
NCT00621803终止不适用

Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients

University Hospital, Clermont-Ferrand0 个研究点目标入组 400 人开始时间: 2003年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
400
主要终点
Delay in P.aeruginosa colonisation

研究概览

简要总结

Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.

详细描述

In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • more than 18 years old
  • length of stay longer than 48h
  • with a nasogastric feeding tube

排除标准

  • - less than 18 years old
  • length of stay < 48h
  • immunosuppression
  • absolute neutrophile count < 500/mm3
  • gastro-intestinal bleeding
  • contraindicated enteral feeding
  • positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission

结局指标

主要结局

Delay in P.aeruginosa colonisation

次要结局

  • Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

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