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临床试验/NCT00566306
NCT00566306已完成不适用

Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation

University of Helsinki0 个研究点目标入组 200 人开始时间: 2007年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization.

研究概览

简要总结

The aim of this study is to 1) test the efficacy of PHMG-based disinfectant against C. difficile spores, 2) test whether it reduces the incidence of C. difficile associated disease (CDAD) and 3) evaluate cost.

详细描述

Environmental disinfection has been proved to be efficient when controlling epidemics caused by C. difficile. In recent years its epidemiology has changed leading to increased morbidity and mortality in many countries. C. difficile infections are often difficult to treat and reinfections frequently occur. The major concern is a new strain of C. difficile, O27, which produce many times more spores than other types and spreads easily in institutions. Patients who have a C. difficile infection should be kept in contact isolation in hospitals and other institutions.

C. difficile is a spore forming bacteria which is resistant to some normally used disinfectants like alcohol and quats. Spores may remain viable for months in environment. Disinfectants currently in use, like chloramines and glutaralde-hyde, are risk both for workers and to environment because of their corrosive and irritating nature.

Polyhexamethyleneguanidine(PHMG) is a new disinfectant which is effective against microbes including bacteria and bacterial spores, viruses and fungi, safe to people handling it and friendly to environment and surfaces. It has been tested in the laboratory of Helsinki University according to many EN-standards to disinfectants. It can be used as a hand disinfectant, instrument disinfectant and surface disinfectant.

PHMG was introduced in three wards for hand hygiene and environmental disinfection in CDAD patients' rooms. The rooms for showers and toilets were coated with biocide coating (PHMG) as well as bed frames in investigational wards. Three wards were control wards and continued using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines. After 6 month's intervention period, the incidence of CDAD cases were compared to that during the preceeding 10 months. Surveillance for environmental and HCWs´ hand contamination by C. difficile were performed by taking microbiological samples both from environmental sites and hands twice before intervention and then twice in month within intervention period.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •( classified as a HCF-onset, HCF-associated CDAD )
  • •toxin or culture positive C difficile
  • •symptom onset more than 72 hours after admission to hospital
  • •symptom onset less than 4 weeks after discharge

排除标准

  • •recurrence of CDAD within 8 weeks
  • •symptom onset before admission to hospital or less than 72 hours after admission to hospital

研究组 & 干预措施

A

Experimental

PHMG will be introduced in three wards for hand hygiene and environmental disinfection in CDAD patients' rooms. The rooms for showers and toilets will be coated with biocide coating (PHMG) as well as bed frames in investigational wards.

干预措施: Polyhexamethyleneguanidine (PHMG) (Other)

B

No Intervention

Three wards will be control wards and continue using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines.

结局指标

主要结局

Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization.

时间窗: 2/07-5/08

次要结局

  • Economical: to evaluate cost of C difficile infection(2/07-5/08)

研究者

申办方类型
Other

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