Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation - Full Text View

Sponsors and Collaborators:	Helsinki University Soft Protector TEKES
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00566306

Purpose

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.

Condition	Intervention
Clostridium Difficile	Other: Polyhexamethyleneguanidine (PHMG)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization. [ Time Frame: 2/07-5/08 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Economical: to evaluate cost of C difficile infection [ Time Frame: 2/07-5/08 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Other: Polyhexamethyleneguanidine (PHMG) 6 months in 3 experimental wards
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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566306

Sponsors and Collaborators

Helsinki University

Soft Protector

TEKES

Investigators

Principal Investigator:

Mari Kanerva, MD,PhD

Helsinki University Central Hospital, Department of Medicine, Division of Infectious Diseases

More Information

Responsible Party:	HUCH,Department of Medicine, Division of Infectious Diseases ( Mari Kanerva )
Study ID Numbers:	231109
Study First Received:	November 30, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00566306
Health Authority:	Finland: Ethics Committee

Keywords provided by Helsinki University:

Clostridium difficile
disinfectant

ClinicalTrials.gov processed this record on January 16, 2009