Clostridium DifficileEFFICACINCT03223415
Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections
A study testing Detection and isolation of C. difficile carriers in people with Clostridium Difficile, run by Yves Longtin at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Detection and isolation of C. difficile carriers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,138 participants
- Where
- 5 sitesCanada
- Study dates
- 25 Aug 2017to 2 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3S 1Y9
McGill University Health Center
Montreal, Quebec, H4A 3J1
Centre Hospitalier Sainte-Marie
Trois-Rivières, Quebec, G8Z 3R9
About this study
Official title: 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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Clostridium Difficile
- Being tested
- Detection and isolation of C. difficile carriers
- Keywords
- Clostridium difficile infection, Infection Control, Prevention, Asymptomatic carriage, Colonization, Pilot Study, Contact Precaution, Detection
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection and isolation of C. difficile carriersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Detection and isolation of C. difficile carriers Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start25 Aug 2017
- Primary completion1 Apr 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yves Longtin
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company, Sir Mortimer B. Davis - Jewish General Hospital
- Responsible party
- Sponsor-investigator, Yves Longtin, Jewish General Hospital
- Investigators
- Yves Longtin, MD, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223415
- Sponsor's protocol ID
- MM-CODIM-MBM-16-264
- Other IDs
- BDS-MCDIF04
- Acronym
- EFFICACI
- Status last verified
- Sep 2020
- First submitted
- 25 May 2017
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27111806
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections; A Cluster Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT03223415
- Acronym / sponsor ID
- EFFICACI / MM-CODIM-MBM-16-264
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium difficile infection, Infection Control, Prevention, Asymptomatic carriage, Colonization, Pilot Study, Contact Precaution, Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,138 participants (actual)
- Lead sponsor
- Yves LongtinUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company, Sir Mortimer B. Davis - Jewish General Hospital
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Detection and isolation of C. difficile carriersDetection 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection and isolation of C. difficile carriersScreening 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. | Other | Experimental arm |
Primary outcome
Rate of admission screening for C. difficile carriage
Time frame: 8 weeks
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
4 secondary outcomes
Healthcare worker compliance with the isolation precautions
Time frame: 8 weeks
Rate of rejection of screening assays
Time frame: 8 weeks
Healthcare worker compliance with hand washing
Time frame: 8 weeks
Proportion of screening assays with proper turnaround time
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Background: PubMed 27111806Longtin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Longtin, MD principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection and isolation of C. difficile carriers in people with Clostridium Difficile, run by Yves Longtin at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of admission screening for C. difficile carriage (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.