Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infect… (NCT03223415) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections
Canada4,138 participantsStarted 2017-08-25
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 criter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of admission screening for C. difficile carriage