NCT00566306

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

November 30, 2007

Last Update Submit

August 25, 2008

Conditions

Clostridium Difficile

Keywords

Clostridium difficiledisinfectant

Outcome Measures

Primary Outcomes (1)

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

    2/07-5/08

Secondary Outcomes (1)

  • Economical: to evaluate cost of C difficile infection

    2/07-5/08

Study Arms (2)

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)

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.

Interventions

Polyhexamethyleneguanidine (PHMG)OTHER

6 months in 3 experimental wards

Also known as: Desisoft
A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • toxin or culture positive C difficile
  • symptom onset more than 72 hours after admission to hospital
  • symptom onset less than 4 weeks after discharge

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

polyhexamethyleneguanidine

Study Officials

  • Mari Kanerva, MD,PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 3, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

August 26, 2008

Record last verified: 2008-08