Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections

Summary

Background: There is an urgent need to develop new strategies to prevent Clostridium difficile infections (CDI). A recent study suggests that a novel infection control bundle (IC bundle) can lead to a significant decrease in the incidence of CDI in acute-care hospitals. This IC bundle consists in screening patients for C. difficile carriage upon their admission combined with implementation of isolation precautions for carriers. Further investigations are required to confirm these findings.

Objective: To evaluate the feasibility of implementing a multicenter interventional study to further to investigate the efficacy of this IC bundle.

Methods: Prospective, cluster randomized feasibility trial of 2 infection control strategies (a "standard" and an "experimental" strategy) to reduce transmission of C. difficile among patients in 20 medical wards in 5 acute-care facilities in Quebec. Wards will be randomized (1:1) to one of the 2 interventions. Each intervention will be applied to all patients present on selected wards. The study will be divided into (1) a 3-month baseline period; (2) a 2-week randomization and implementation period; and (3) an 8-week intervention period.

Intervention: The "experimental strategy" includes the components of the above-mentioned IC bundle. The "standard strategy" will not implement the IC bundle.

Outcomes: As a feasibility study, process evaluation will form the primary and secondary outcomes. These outcomes will allow to determine whether a future main trial is possible and desirable.

Hypothesis: We hypothesize that the intervention will be implementable across the study wards.

Significance: This study is essential to plan a subsequent definitive trial to determine whether the IC bundle can prevent CDI.

Conditions

• Clostridium Difficile

Interventions

OTHER

Detection and isolation of C. difficile carriers

Screening for C. difficile carriage will be conducted by performing a polymerase chain reaction (PCR) assay detecting the toxin B gene (tcdB) on a rectal swab. Screening will occur within 24 h of admission to the ward. To ensure compliance with the policy, automatic orders will be developed. The patient care nurse will perform the screenings. The results will be reported according to the standard institutional policy. Isolation precautions for C. difficile carriers: healthcare workers will also follow a set of isolation precaution rules during the care of C. difficile carriers. C. difficile carriers will remain under isolation precaution as long as they remain carriers and on the intervention ward. Precautions would be discontinued upon discharge from the ward.

Sponsors & Collaborators

• Becton, Dickinson and Company

  collaborator INDUSTRY

• Sir Mortimer B. Davis - Jewish General Hospital

  collaborator OTHER

• Yves Longtin

  lead OTHER

Principal Investigators

• Yves Longtin, MD · Sir Mortimer B. Davis - Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-25

Primary Completion

2018-04-01

Completion

2018-05-02

Countries

• Canada

Study Locations