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

NCT03223415 | Completed

• 2 other identifiers: MM-CODIM-MBM-16-264BDS-MCDIF04
• Study Type: interventional
• Target: 4,138
• Locations: 1 country
• Sites: 5

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.

Conditions

Clostridium Difficile

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Healthcare worker compliance with the isolation precautions

  8 weeks

• Rate of rejection of screening assays

  8 weeks

• Healthcare worker compliance with hand washing

  8 weeks

• Proportion of screening assays with proper turnaround time

  8 weeks

Study Arms (2)

Experimental arm

EXPERIMENTAL

Detection and isolation of C. difficile carriers

Other: Detection and isolation of C. difficile carriers

Control arm

NO INTERVENTION

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

Interventions

Detection and isolation of C. difficile carriers OTHER

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.

Experimental arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Yves Longtin: lead
• Becton, Dickinson and Company: collaborator
• Sir Mortimer B. Davis - Jewish General Hospital: collaborator

Study Sites (5)

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Sainte-Marie

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Related Publications (1)

• 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.

  PMID: 27111806 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Yves Longtin, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Infection Prevention and Control Unit

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: July 21, 2017
• Study Start: August 25, 2017
• Primary Completion: April 1, 2018
• Study Completion: May 2, 2018
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)