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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
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile focused on measuring Clostridium difficile, disinfectant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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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