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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile
• Intervention / Treatment: Other: Polyhexamethyleneguanidine (PHMG)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 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; Other Names: Desisoft
No Intervention: B; Three wards will be control wards and continue using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical: C. difficile infections on study wards. Microbiologic: C difficile colonization.	2/07-5/08

Secondary Outcome Measures

Outcome Measure	Time Frame
Economical: to evaluate cost of C difficile infection	2/07-5/08

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Soft Protector; The Finnish Funding Agency for Technology and Innovation (TEKES)
• Investigators: Principal Investigator: Mari Kanerva, MD,PhD, Helsinki University Central Hospital, Department of Medicine, Division of Infectious Diseases

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 3, 2007

Study Record Updates

• Last Update Posted (Estimate): August 26, 2008
• Last Update Submitted That Met QC Criteria: August 25, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Clostridium difficile; disinfectant
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: 231109