Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation
Primary Purpose
Clostridium Difficile
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polyhexamethyleneguanidine (PHMG)
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile focused on measuring Clostridium difficile, disinfectant
Eligibility Criteria
Inclusion Criteria: ( 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
Exclusion Criteria:
- recurrence of CDAD within 8 weeks
- symptom onset before admission to hospital or less than 72 hours after admission to hospital
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
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.
Three wards will be control wards and continue using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines.
Outcomes
Primary Outcome Measures
Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization.
Secondary Outcome Measures
Economical: to evaluate cost of C difficile infection
Full Information
NCT ID
NCT00566306
First Posted
November 30, 2007
Last Updated
August 25, 2008
Sponsor
University of Helsinki
Collaborators
Soft Protector, The Finnish Funding Agency for Technology and Innovation (TEKES)
1. Study Identification
Unique Protocol Identification Number
NCT00566306
Brief Title
Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation
Official Title
Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
Soft Protector, The Finnish Funding Agency for Technology and Innovation (TEKES)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile
Keywords
Clostridium difficile, disinfectant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Arm Title
B
Arm Type
No Intervention
Arm Description
Three wards will be control wards and continue using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines.
Intervention Type
Other
Intervention Name(s)
Polyhexamethyleneguanidine (PHMG)
Other Intervention Name(s)
Desisoft
Intervention Description
6 months in 3 experimental wards
Primary Outcome Measure Information:
Title
Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization.
Time Frame
2/07-5/08
Secondary Outcome Measure Information:
Title
Economical: to evaluate cost of C difficile infection
Time Frame
2/07-5/08
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ( 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
Exclusion Criteria:
recurrence of CDAD within 8 weeks
symptom onset before admission to hospital or less than 72 hours after admission to hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mari Kanerva, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital, Department of Medicine, Division of Infectious Diseases
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation
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