Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections (EFFICACI)

Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections; A Cluster Randomized Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile
• Intervention / Treatment: Other: Detection and isolation of C. difficile carriers

Detailed Description

C. difficile is a gram-negative anaerobic bacteria that causes C. difficile infection (CDI), a disease involving the colon and causing symptoms ranging from mild diarrhea to fulminant colitis. C. difficile can spread from patients to patients in acute-care hospitals. Transmission is believed to occur mainly from patients with active disease, but patients who carry the bacteria without any symptom (called C. difficile carriers) can also transmit the bacteria to other patients.

Preliminary evidence that suggest that detecting C. difficile carriers to place them under isolation precautions can lead to a decrease in the incidence of CDI. In order to investigate this question, large-scale clinical trials will be ultimately required. In order to plan such large-scale study, there is a need to perform a preliminary feasibility trial. The current study will assess the feasibility, acceptability and logistical considerations of implementing a multicenter intervention consisting of the detection and isolation of C. difficile carriers on hospital admission, in order to guide the design of a definitive trial. This objective is essential considering the paucity of published data on this topic.

• Study Type: Interventional
• Enrollment (Actual): 4138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health center
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montréal, Quebec, Canada, H3S 1Y9
      • Jewish General Hospital
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre Hospitalier Sainte-Marie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Because both strategies will be applied at the ward level, the inclusion and exclusion criteria apply to wards, not to individual patients. All patients and healthcare workers on each ward will be assigned to the intervention.

Inclusion criteria:

Clusters (i.e. wards) are eligible to take part in the study if they meet the following criteria:

• Adult medical or surgical wards;
• Patient volume: ≥5 admissions/month and ≥600 patient days/month in 2015;
• Incidence rate of CDI of ≥5/10 000 patient-days based during in 2014-2015;
• Commitment by the hospital administration to have the hospital undergo randomization for the trial (Willingness to be randomized in either arm of the study);
• Institutional agreement to screen all eligible new admissions for CD carriers and isolate CD carriers in accordance with the study protocol;
• Signed protocol signature page indicating willingness to enroll the ward in the study from the director of the hospital;
• Capacity to implement protocol (screening, isolation, respect of contact precautions);
• Capacity to screen patients by PCR with a turnaround time of <24 h;
• Participation in the Quebec CDI surveillance program (SPIN-CD);
• No existing protocol to detect and isolate CD carriers (isolation of CDI patients with resolved diarrhea allowed);
• Stable use of infection-prevention initiatives and products during the baseline period;
• Agreement to refrain from adopting new initiatives that would conflict with the trial.

Exclusion criteria:

• Wards planning to enroll subjects in other studies that aim to eradicate or prevent colonization with C. difficile or management strategies that have CD carriers or CDI as an outcome.
• Gender-biased wards (gynecology/ obstetrics, urology).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental arm; Detection and isolation of C. difficile carriers	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.
NO_INTERVENTION: Control arm; No detection of C. difficile carriers upon admission and no implementation of contact isolation precautions for C. difficile carriers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of admission screening for C. difficile carriage	Rate of admission screening for C. difficile carriage, defined as the number of patients who were screened on admission divided by the number of admitted patients per 4-week period	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare worker compliance with the isolation precautions	Healthcare worker compliance with the isolation precautions, defined as the number of opportunities in which healthcare workers complied with the isolation precaution upon entering the room of a C. difficile carrier divided by the total number of healthcare workers who entered the room.	8 weeks
Rate of rejection of screening assays	Rate of rejection of rectal swabs, defined as the number of rectal swabs submitted to the laboratory for C. difficile screening assay that were rejected for any reason divided by the total number of rectal swabs submitted for C. difficile screening assay per 4-week period.	8 weeks
Healthcare worker compliance with hand washing	Healthcare worker compliance with hand washing, defined as the number of opportunities in which healthcare workers complied with the hand washing policy upon exiting the room of a C. difficile carrier divided by the total number of hand washing opportunities upon exiting the room of a C. difficile carrier.	8 weeks
Proportion of screening assays with proper turnaround time	Proportion of screening assays with proper turnaround time, defined as the number of screening samples with a < 24 hour turnaround time (TAT) divided by the number of screening samples submitted to the laboratory.	8 weeks

Collaborators and Investigators

• Sponsor: Yves Longtin
• Collaborators: Sir Mortimer B. Davis - Jewish General Hospital; Becton, Dickinson and Company
• Investigators: Principal Investigator: Yves Longtin, MD, Sir Mortimer B. Davis - Jewish General Hospital

Publications and helpful links

General Publications

• Longtin Y, Paquet-Bolduc B, Gilca R, Garenc C, Fortin E, Longtin J, Trottier S, Gervais P, Roussy JF, Levesque S, Ben-David D, Cloutier I, Loo VG. Effect of Detecting and Isolating Clostridium difficile Carriers at Hospital Admission on the Incidence of C difficile Infections: A Quasi-Experimental Controlled Study. JAMA Intern Med. 2016 Jun 1;176(6):796-804. doi: 10.1001/jamainternmed.2016.0177.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2017
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): May 2, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 26, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Detection; Prevention; Colonization; Clostridium difficile infection; Infection Control; Pilot Study; Asymptomatic carriage; Contact Precaution
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Clostridium Infections
• Other Study ID Numbers: MM-CODIM-MBM-16-264; BDS-MCDIF04 (OTHER: Becton, Dickinson and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No