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

Primary Purpose

Clostridium Difficile

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Detection and isolation of C. difficile carriers

About this trial

This is an interventional prevention trial for Clostridium Difficile focused on measuring Clostridium difficile infection, Infection Control, Prevention, Asymptomatic carriage, Colonization, Pilot Study, Contact Precaution, Detection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Hopital Charles Lemoyne
Montreal General Hospital
McGill University Health Center
Jewish General Hospital
Centre Hospitalier Sainte-Marie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental arm

Control arm

Arm Description

Detection and isolation of C. difficile carriers

No detection of C. difficile carriers upon admission and no implementation of contact isolation precautions for C. difficile carriers

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03223415

First Posted

May 25, 2017

Last Updated

September 26, 2020

Sponsor

Yves Longtin

Collaborators

Becton, Dickinson and Company, Sir Mortimer B. Davis - Jewish General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03223415

Brief Title

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

Acronym

EFFICACI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

August 25, 2017 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yves Longtin

Collaborators

Becton, Dickinson and Company, Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile

Keywords

Clostridium difficile infection, Infection Control, Prevention, Asymptomatic carriage, Colonization, Pilot Study, Contact Precaution, Detection

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Detection and isolation of C. difficile carriers

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

No detection of C. difficile carriers upon admission and no implementation of contact isolation precautions for C. difficile carriers

Intervention Type

Other

Intervention Name(s)

Detection and isolation of C. difficile carriers

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of admission screening for C. difficile carriage

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Healthcare worker compliance with the isolation precautions

Description

Time Frame

8 weeks

Title

Rate of rejection of screening assays

Description

Time Frame

8 weeks

Title

Healthcare worker compliance with hand washing

Description

Time Frame

8 weeks

Title

Proportion of screening assays with proper turnaround time

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Longtin, MD

Organizational Affiliation

Sir Mortimer B. Davis - Jewish General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Charles Lemoyne

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Montreal General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

McGill University Health Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Jewish General Hospital

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3S 1Y9

Country

Canada

Facility Name

Centre Hospitalier Sainte-Marie

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8Z 3R9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27111806

Citation

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.

Results Reference

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

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