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Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection (TAPER-V)

Primary Purpose

Clostridium Difficile Infection

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Vancomycin
Placebos
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All consecutive adult patients (inpatients and outpatients) who have a treated first episode or first recurrence of CDI.
  • CDI will be defined by a positive PCR for toxin gene and/or detection of toxin by EIA or CCA along with three or more episodes of diarrhea within 24 hours
  • Patients with a positive test with less than three bowel movements may be included if they initially presented with ileus or if they had pseudomembranous colitis visualized on colonoscopy

Exclusion Criteria:

  • Clinical:

    1. Toxic megacolon at presentation not resolved by day 10
    2. For the current episode of CDI: use of metronidazole monotherapy*, fidaxomicin, fecal microbiota transplant or intravenous immunoglobulins

      *Participants may be eligible if they are initially treated with metronidazole but switch to oral vancomycin within 3 days (i.e. maximum 3 days of metronidazole monotherapy).

    3. Previous or current colectomy
    4. Severe allergy/intolerance to oral vancomycin
    5. Patient is expected to die within 3 months from another disease or is expected to be admitted to a palliative care unit
    6. Failure to achieve clinical cure (as above) by day 10
    7. More than 2 episodes of C. difficile in the last 5 years.
    8. Documented history of sensorineural hearing loss (other than presbycusis and noise induced hearing loss). The following patients with documented previous subtypes of sensorineural hearing loss will be excluded from the trial: Menière's disease, multiple sclerosis affecting auditory nerves, otic syphilis, viral cochleitis, autoimmune disorders, previous drug induced hearing loss, and otherwise unexplained sudden sensorineural hearing loss (SSNHL)
    9. Known pregnancy or planning to become pregnant during the study period
    10. Women who are breast feeding
  • Administrative:

    1. Expected transfer to a palliative care unit or non-study hospital;
    2. No provincial health insurance
    3. Previously enrolled
    4. No reliable means of outpatient contact
    5. Incompetent without healthcare proxy
    6. Patient stated inability to come to follow up appointments.

Sites / Locations

  • Vancouver General HospitalRecruiting
  • Sunnybrook Health Science CentreRecruiting
  • St. Michael's HospitalRecruiting
  • University Health NetworkRecruiting
  • McGill University Health Centre (Royal Victoria Hospital)Recruiting
  • Jewish General HospitalRecruiting
  • Centre hospitalier universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control: Placebo

Intervention: Extended vancomycin regimen

Arm Description

Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive a placebo for an additional 14 days (twice a day x 7 days, then once a day for 7 days).

Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive active vancomycin for an additional 14 days (125mg twice a day x 7 days, then 125mg once a day for 7 days).

Outcomes

Primary Outcome Measures

CDI recurrence
Patients will be contacted via text message, email, or phone call weekly until day 56 to determine if they have had a recurrence. After day 56 this will be bi-weekly until day 90. Recurrence will be assessed by clinical record review (chart, laboratory, pharmacy records) and direct patient interview. Blinded case summaries will be reviewed in duplicate with disagreement resolved by consensus. CDI recurrence will be defined by three or more diarrheal stools/24-hour period coupled with a positive PCR for toxin gene or and/or detection of toxin by EIA or CCA and administration of treatment. However, to avoid missing severe recurrences: for cases of ileus, toxic megacolon, or pseudomembranous colitis on colonoscopy the test result will be used in the absence of three or more stools.

Secondary Outcome Measures

Late CDI recurrence
same as primary outcome
Use of fidaxomicin
Number of patients with colectomy
Number of patients with fecal microbiota transplantation
Number of patient deaths (All-cause death)
If a patient misses their day 28 or day 56 in-person follow up, we will initially review their hospital file to see if they have died. If this does not show death, we will contact the patient (or their proxy) by telephone to determine why they missed the follow up and reschedule it as required. If we cannot reach the patient or their proxy, and the patient has not been replying to the email/text/phone surveys we will search the obituaries. After day 56 we will use the survey responses as proof of life. If there is no response to the day 90 survey by day 95, we will first check the hospital file to see if they have died. Then, if vital status is not clear, we will search the obituaries. Then if vital status is still not clear, we will attempt to reach the patient by telephone. If we cannot reach the patient, we will record that patient as lost to follow up but include a sensitivity analysis including these patients as having died.
C. diff associated quality of life
At day 56 patients will be asked to provide a measure of self-reported quality of life using the Cdiff32 score which was developed and validated to evaluate health-related quality of life in patients with C.difficile. Each item in the Cdiff32 Quality of Life Questionnaire is scored between 0 (worst quality of life) to 100 (best quality of life).
Emergency department visits
Within 90 days post enrolment we will access the medical record and we will also analyze patient emails/text surveys for all emergency department visits and will record the date of the first emergency department visit. Patient charts will also be flagged for immediate review should they visit the emergency room or be admitted to study centres to assess for the primary and other secondary outcomes. With explicit written patient consent, medical records from outside hospitals will be also requested for review if they report presenting elsewhere.
Re-admission to hospital
Within 90 days post enrolment we will access the medical record and we will also analyze patient emails/text surveys for all hospital readmissions and will record the date of the first hospital readmission. Patient charts will also be flagged for immediate review should they be readmitted to study centres to assess for the primary and other secondary outcomes. With explicit written patient consent, medical records from outside hospitals will also be requested for review if they report presenting elsewhere.
Discontinuation of study drug
At the day 28 visit we will inquire about adherence and the quantity of pills remaining.
Receipt of non-study antibiotics
Exposure to antibiotics for infections other than C. difficile may occur. We will ask patients to contact us if this occurs so that the appropriate data can be recorded to account for these effects outside of the study.
Use of off-study vancomycin secondary prophylaxis up to day 90
Exposure to antibiotics for other infections may lead to the receipt of vancomycin secondary prophylaxis in that context. We will ask patients to contact us if this occurs so that the appropriate data can be recorded to account for these effects outside of the study. If vancomycin secondary prophylaxis has occurred prior to day 28, the patient will stop the study drug to avoid excess vancomycin exposure and this will be recorded.
Economic analysis
Economic analysis will be carried out from the perspective of the McGill University Health Centre (MUHC) following established guidelines and will be generalized to the rest of Canada. We will estimate the average cost per patient of using the interventions under study routinely in patients with C. difficile diarrhea. We will also gather information on the cost of health services use (hospitalizations and other interventions such as colectomy) following this intervention to determine the budget impact compared with routine practice. If the intervention proves efficacious, we will carry out a cost-benefit or cost-effectiveness analysis to determine the incremental cost per case of C. difficile diarrhea avoided. The base case will be the placebo group, to which the treatment will be compared. Further, we will carry out a cost utility analysis to report the incremental cost per unit increase in quality of life as measured by the Cdiff32 score.
Safety & tolerability of the vancomycin extension/taper treatment period
We will create a survey at day 28 asking participants to communicate any side effects from the study medication, with a section for detailing any adverse reactions.

Full Information

First Posted
October 22, 2019
Last Updated
March 30, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04138706
Brief Title
Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection
Acronym
TAPER-V
Official Title
Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada (AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%, approximately 25% of patients who have a complete response will develop recurrence (rCDI) within 8 weeks. Doctors' ability to predict recurrence is evolving, but remains very limited. The investigators hypothesize that by extending initial vancomycin therapy with a 2-week tapering regimen this will reduce the risk of rCDI. Starting at the end of the initial 14 days of therapy, participants will be randomized to receive an additional 14-days of placebo or vancomycin taper (125 mg orally twice daily x 7 days followed by 125 mg orally once daily x 7 days). This taper was chosen as it represents two steps of a commonly used 4-week vancomycin taper. The investigators' proposal to evaluate the extension of initial treatment from 14 to 28 days with a tapering dose of vancomycin represents a practical clinical trial that capitalizes on oral vancomycin's safety profile, worldwide availability, and relatively low cost.
Detailed Description
STUDY POPULATION This is a multi-centre study involving institutions in British Columbia, Ontario and Quebec. The study population will be drawn from patients cared for as inpatients or outpatients at the participating hospitals. Such patients will have a test positive for Clostridium difficile and will be receiving treatment. The trial will involve only adult patients 18 years of age and older. Criteria for Recruitment The microbiology laboratory will notify the study team about a positive CDI test via telephone, email, or fax. The nature of recruitment will then depend on the inpatient status of the patient at the time of the test. Inpatients: Pre-existing approval for approaching patients for this study will be obtained from the relevant department heads. The study team will speak with a member of the inpatient treating team (resident physician or faculty physician as appropriate) to determine if the patient is appropriate for recruitment. If this seems to be the case, the patient's file will be rapidly screened to determine eligibility and if the patient is eligible they will be approached for consent. Outpatients: The physician who ordered the C. difficile test will be contracted to determine if the patient is appropriate for recruitment. At the invitation of this physician, the investigators will then contact the patient via telephone to evaluate suitability for inclusion and arrange an intake visit. RANDOMIZATION For patients who have enrolled in the study, randomization will occur centrally at McGill via an existing internet application (such as https://cloudtrials.mchi.mcgill.ca/) and will be performed by permuted block with randomized block sizes. This randomization will be stratified for first episode or first recurrence at study entry to ensure these factors are properly balanced. TRIAL SCHEDULE Day 1: Patient diagnosed with C. difficile and started on standard of care oral vancomycin treatment -> Determine eligibility and obtain permission for approach Day 7-10 (Patient's C. difficile has improved and meets eligibility): Consent obtained; randomization; distribution of study drug for day 15 start -> Collection of demographics, storage of stool. Day 15-28 -> Receipt of study therapy Day 28: In person or remote visit Day 56: In person or remote visit -> Primary outcome determined, quality of life questionnaire Day 90: Study ends for the patient -> Secondary outcomes can be determined weekly until Day 56: Brief questionnaire -> By email/text/phone biweekly after Day 56: Brief questionnaire -> By email/text/phone Ad hoc: If patient has symptoms of recurrence of C. difficile -> Review by ID physician in clinic if possible, otherwise usual doctors or emergency room Patients will be able to come be assessed for potential relapse by infectious diseases physicians at each site (who may or may not be a part of the study) or could see their usual doctors. SAMPLE SIZE AND STATISTICAL METHODS The estimated number of CDI cases available has been based on fiscal year 2016 data: total of 1770 per year. The risk of recurrence is estimated at 25%. The investigators aim to demonstrate that an initial tapering regimen is associated with an absolute decrease in the risk of relapse of at least 10% (number needed to treat of 10) which would be similar to the effect seen within 40 days in the fidaxomicin trial. This estimate accounts for our longer period of follow up and will allow some flexibility in the actual recurrence rate found in our control arm. With 80% power and a type 1 error of 5%, this would require 276 patients to complete follow up in each arm (total 552).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded placebo-controlled randomized controlled trial: A double blind and placebo will be used because the knowledge of being on active drug might influence patient reporting on gastrointestinal symptoms or physician interpretation of such symptoms leading to asymmetrical workup of CDI recurrence and hence bias in the results. To avoid other sources of bias post-randomization, patients, research personnel, investigators, endpoint adjudicators, and study analysis will all remain blinded to the intervention status until completion of the analysis and reporting of results. Analysis will be performed by intention to treat.
Allocation
Randomized
Enrollment
552 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control: Placebo
Arm Type
Placebo Comparator
Arm Description
Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive a placebo for an additional 14 days (twice a day x 7 days, then once a day for 7 days).
Arm Title
Intervention: Extended vancomycin regimen
Arm Type
Active Comparator
Arm Description
Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive active vancomycin for an additional 14 days (125mg twice a day x 7 days, then 125mg once a day for 7 days).
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Extension of initial vancomycin regimen for the treatment of C. diff from 14 days to 28 days (i.e. an additional 14 days of vancomycin treatment)
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Initial vancomycin treatment (x14 days) will be followed by 14 days of placebo.
Primary Outcome Measure Information:
Title
CDI recurrence
Description
Patients will be contacted via text message, email, or phone call weekly until day 56 to determine if they have had a recurrence. After day 56 this will be bi-weekly until day 90. Recurrence will be assessed by clinical record review (chart, laboratory, pharmacy records) and direct patient interview. Blinded case summaries will be reviewed in duplicate with disagreement resolved by consensus. CDI recurrence will be defined by three or more diarrheal stools/24-hour period coupled with a positive PCR for toxin gene or and/or detection of toxin by EIA or CCA and administration of treatment. However, to avoid missing severe recurrences: for cases of ileus, toxic megacolon, or pseudomembranous colitis on colonoscopy the test result will be used in the absence of three or more stools.
Time Frame
Within 56 days of initial vancomycin treatment start date
Secondary Outcome Measure Information:
Title
Late CDI recurrence
Description
same as primary outcome
Time Frame
Up to 90 days following initial vancomycin treatment start date
Title
Use of fidaxomicin
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Number of patients with colectomy
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Number of patients with fecal microbiota transplantation
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Number of patient deaths (All-cause death)
Description
If a patient misses their day 28 or day 56 in-person follow up, we will initially review their hospital file to see if they have died. If this does not show death, we will contact the patient (or their proxy) by telephone to determine why they missed the follow up and reschedule it as required. If we cannot reach the patient or their proxy, and the patient has not been replying to the email/text/phone surveys we will search the obituaries. After day 56 we will use the survey responses as proof of life. If there is no response to the day 90 survey by day 95, we will first check the hospital file to see if they have died. Then, if vital status is not clear, we will search the obituaries. Then if vital status is still not clear, we will attempt to reach the patient by telephone. If we cannot reach the patient, we will record that patient as lost to follow up but include a sensitivity analysis including these patients as having died.
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
C. diff associated quality of life
Description
At day 56 patients will be asked to provide a measure of self-reported quality of life using the Cdiff32 score which was developed and validated to evaluate health-related quality of life in patients with C.difficile. Each item in the Cdiff32 Quality of Life Questionnaire is scored between 0 (worst quality of life) to 100 (best quality of life).
Time Frame
At day 56 after initial vancomycin treatment start date
Title
Emergency department visits
Description
Within 90 days post enrolment we will access the medical record and we will also analyze patient emails/text surveys for all emergency department visits and will record the date of the first emergency department visit. Patient charts will also be flagged for immediate review should they visit the emergency room or be admitted to study centres to assess for the primary and other secondary outcomes. With explicit written patient consent, medical records from outside hospitals will be also requested for review if they report presenting elsewhere.
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Re-admission to hospital
Description
Within 90 days post enrolment we will access the medical record and we will also analyze patient emails/text surveys for all hospital readmissions and will record the date of the first hospital readmission. Patient charts will also be flagged for immediate review should they be readmitted to study centres to assess for the primary and other secondary outcomes. With explicit written patient consent, medical records from outside hospitals will also be requested for review if they report presenting elsewhere.
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Discontinuation of study drug
Description
At the day 28 visit we will inquire about adherence and the quantity of pills remaining.
Time Frame
At day 28 after initial vancomycin treatment start date
Title
Receipt of non-study antibiotics
Description
Exposure to antibiotics for infections other than C. difficile may occur. We will ask patients to contact us if this occurs so that the appropriate data can be recorded to account for these effects outside of the study.
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Use of off-study vancomycin secondary prophylaxis up to day 90
Description
Exposure to antibiotics for other infections may lead to the receipt of vancomycin secondary prophylaxis in that context. We will ask patients to contact us if this occurs so that the appropriate data can be recorded to account for these effects outside of the study. If vancomycin secondary prophylaxis has occurred prior to day 28, the patient will stop the study drug to avoid excess vancomycin exposure and this will be recorded.
Time Frame
Within 90 days of initial vancomycin treatment start date
Title
Economic analysis
Description
Economic analysis will be carried out from the perspective of the McGill University Health Centre (MUHC) following established guidelines and will be generalized to the rest of Canada. We will estimate the average cost per patient of using the interventions under study routinely in patients with C. difficile diarrhea. We will also gather information on the cost of health services use (hospitalizations and other interventions such as colectomy) following this intervention to determine the budget impact compared with routine practice. If the intervention proves efficacious, we will carry out a cost-benefit or cost-effectiveness analysis to determine the incremental cost per case of C. difficile diarrhea avoided. The base case will be the placebo group, to which the treatment will be compared. Further, we will carry out a cost utility analysis to report the incremental cost per unit increase in quality of life as measured by the Cdiff32 score.
Time Frame
Cost of health care utilization up to 90 days after initial vancomycin treatment start date
Title
Safety & tolerability of the vancomycin extension/taper treatment period
Description
We will create a survey at day 28 asking participants to communicate any side effects from the study medication, with a section for detailing any adverse reactions.
Time Frame
Days 15-28 of vancomycin treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consecutive adult patients (inpatients and outpatients) who have a treated first episode or first recurrence of CDI. CDI will be defined by a positive PCR for toxin gene and/or detection of toxin by EIA or CCA along with three or more episodes of diarrhea within 24 hours Patients with a positive test with less than three bowel movements may be included if they initially presented with ileus or if they had pseudomembranous colitis visualized on colonoscopy Exclusion Criteria: Clinical: Toxic megacolon at presentation not resolved by day 10 For the current episode of CDI: use of metronidazole monotherapy*, fidaxomicin, fecal microbiota transplant or intravenous immunoglobulins *Participants may be eligible if they are initially treated with metronidazole but switch to oral vancomycin within 3 days (i.e. maximum 3 days of metronidazole monotherapy). Previous or current colectomy Severe allergy/intolerance to oral vancomycin Patient is expected to die within 3 months from another disease or is expected to be admitted to a palliative care unit Failure to achieve clinical cure (as above) by day 10 More than 2 episodes of C. difficile in the last 5 years. Documented history of sensorineural hearing loss (other than presbycusis and noise induced hearing loss). The following patients with documented previous subtypes of sensorineural hearing loss will be excluded from the trial: Menière's disease, multiple sclerosis affecting auditory nerves, otic syphilis, viral cochleitis, autoimmune disorders, previous drug induced hearing loss, and otherwise unexplained sudden sensorineural hearing loss (SSNHL) Known pregnancy or planning to become pregnant during the study period Women who are breast feeding Administrative: Expected transfer to a palliative care unit or non-study hospital; No provincial health insurance Previously enrolled No reliable means of outpatient contact Incompetent without healthcare proxy Patient stated inability to come to follow up appointments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Elsayed
Phone
5149341934
Ext
23730
Email
sarah.elsayed@idtrials.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd C Lee, MD, MPH
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily G McDonald, MD MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Vasyukhnik
Email
vas1955@mail.ubc.ca
First Name & Middle Initial & Last Name & Degree
Theodore Steiner, MD
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asgar Rishu, MBBS
Email
asgar.rishu@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Nick Daneman, MD MSc
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saman Khan
Email
saman.khan@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Matthew Muller, MD
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masha Kulikova
Email
maria.kulikova@uhnresearch.ca
First Name & Middle Initial & Last Name & Degree
Bryan Coburn, MD
Facility Name
McGill University Health Centre (Royal Victoria Hospital)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Elsayed
Phone
514-934-1934
Ext
23730
Email
sarah.elsayed@idtrials.com
First Name & Middle Initial & Last Name & Degree
Emily G McDonald, MD MSc
First Name & Middle Initial & Last Name & Degree
Todd C Lee, MD MPH
First Name & Middle Initial & Last Name & Degree
Charles H Frenette, MD
First Name & Middle Initial & Last Name & Degree
Vivian G Loo, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Butler-Laporte, MD
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Eastmond
Email
jeastmon@jgh.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Yves Longtin, MD
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Vettese
Email
kim.vettese@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Anaïs Marcil-Heguy
Email
anais.marcil-heguy@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Louis Valiquette, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25875259
Citation
Leffler DA, Lamont JT. Clostridium difficile infection. N Engl J Med. 2015 Apr 16;372(16):1539-48. doi: 10.1056/NEJMra1403772. No abstract available.
Results Reference
background
PubMed Identifier
22752867
Citation
Lessa FC, Gould CV, McDonald LC. Current status of Clostridium difficile infection epidemiology. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S65-70. doi: 10.1093/cid/cis319.
Results Reference
background
PubMed Identifier
26191534
Citation
Levy AR, Szabo SM, Lozano-Ortega G, Lloyd-Smith E, Leung V, Lawrence R, Romney MG. Incidence and Costs of Clostridium difficile Infections in Canada. Open Forum Infect Dis. 2015 Jun 3;2(3):ofv076. doi: 10.1093/ofid/ofv076. eCollection 2015 Sep.
Results Reference
background
PubMed Identifier
12734650
Citation
Dobson G, Hickey C, Trinder J. Clostridium difficile colitis causing toxic megacolon, severe sepsis and multiple organ dysfunction syndrome. Intensive Care Med. 2003 Jun;29(6):1030. doi: 10.1007/s00134-003-1754-7. Epub 2003 May 7. No abstract available.
Results Reference
background
PubMed Identifier
11252111
Citation
Mylonakis E, Ryan ET, Calderwood SB. Clostridium difficile--Associated diarrhea: A review. Arch Intern Med. 2001 Feb 26;161(4):525-33. doi: 10.1001/archinte.161.4.525.
Results Reference
background
PubMed Identifier
25730198
Citation
McDonald EG, Milligan J, Frenette C, Lee TC. Continuous Proton Pump Inhibitor Therapy and the Associated Risk of Recurrent Clostridium difficile Infection. JAMA Intern Med. 2015 May;175(5):784-91. doi: 10.1001/jamainternmed.2015.42.
Results Reference
background
PubMed Identifier
26582748
Citation
Sheitoyan-Pesant C, Abou Chakra CN, Pepin J, Marcil-Heguy A, Nault V, Valiquette L. Clinical and Healthcare Burden of Multiple Recurrences of Clostridium difficile Infection. Clin Infect Dis. 2016 Mar 1;62(5):574-580. doi: 10.1093/cid/civ958. Epub 2015 Nov 17.
Results Reference
background
PubMed Identifier
27817758
Citation
Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2017 Feb;38(2):196-202. doi: 10.1017/ice.2016.246. Epub 2016 Nov 7.
Results Reference
background
PubMed Identifier
25658560
Citation
Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2015 Feb;21(2):164-70. doi: 10.1016/j.cmi.2014.08.017. Epub 2014 Oct 12.
Results Reference
background
PubMed Identifier
29486930
Citation
The Lancet. A new approach to treating infection. Lancet. 2018 Feb 24;391(10122):714. doi: 10.1016/S0140-6736(18)30320-9. No abstract available.
Results Reference
background

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Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection

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