Comparing Fidaxomicin with Vancomycin for clostridia difficile colitis
Official title: Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial
- Phase 3
- 2 groups
- One site, in Montreal
- Recruiting
Interventions
- Medication
Fidaxomicin
Fidaxomicin 200mg PO BID x 10 days
- Medication
Vancomycin capsule
Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for41 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Severe intolerance or allergy to oral vancomycin or fidaxomicin.
- +Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
- +First episode or first recurrence of CDI (i.e., second episode within 120 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and/or cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \<24 hours with a duration \>24 hours, endoscopic/histologic evidence of pseudomembranous colitis, or ileus. For eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →, CDI will be considered a first recurrence if the patient experiences 2 episodes within a 120-day timeframe; those with a first ever episode, or 2 episodes separated by more than 120 days, will be categorized as a first-episode.
- +Clinical Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).
- +Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).
- +Inability to take medications orally.
- +Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
- +The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → from another illness.
- +Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and/or toxic megacolon.
- +Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.
- +Patients who have had ≥3 episodes of CDI in the last 1 year.
- +Treating team declined participation.
- +Prior enrolment in TAPER-V2.
- +Administrative Exclusion Criteria
- +Prior enrollment in this trial.
- +Inability to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → without a healthcare proxy.
- +Lack of health insurance.
- +Anticipated transfer to a siteTrial siteA hospital or clinic where a study is actually run.Read more → not involved in this trial, or to a palliative care ward
- +Patient-declared anticipated inability to participate in study follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → or lack of means for contact in the outpatient setting.
- +Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.
- +Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.
Exclusion
- −Severe intolerance or allergy to oral vancomycin or fidaxomicin.
- −Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).
- −Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).
- −Inability to take medications orally.
- −Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
- −The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → from another illness.
- −Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and/or toxic megacolon.
- −Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.
- −Patients who have had ≥3 episodes of CDI in the last 1 year.
- −Treating team declined participation.
- −Prior enrolment in TAPER-V2.
- −Administrative Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- −Prior enrollment in this trial.
- −Inability to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → without a healthcare proxy.
- −Lack of health insurance.
- −Anticipated transfer to a siteTrial siteA hospital or clinic where a study is actually run.Read more → not involved in this trial, or to a palliative care ward
- −Patient-declared anticipated inability to participate in study follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → or lack of means for contact in the outpatient setting.
- −Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.
- −Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Fidaxomicin.
Registry label: A: Fidaxomicin
Group B receives Vancomycin capsule.
Registry label: B: Vancomycin T-P
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 500 people.
The study is currently expected to finish around November 2030.
The main measurement is taken over: 56 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
CDI Recurrence — measured over 56 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07328971 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About FidaxomicinDrug
Fidaxomicin 200mg PO BID x 10 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vancomycin capsuleDrug
Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 56 days.
The study as a whole is currently expected to finish around 2030-11-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is: 1\) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days of fidaxomicin for the prevention of rCDI at 56 days
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.