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New treatment option for Clostridia Difficile Colitis
Official title Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
ClinicalTrials.gov ID: NCT07328971
What this study is testing
What is Fidaxomicin?
Fidaxomicin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clostridia difficile colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Inability to take medications orally.
- Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
- Severe intolerance or allergy to oral vancomycin or fidaxomicin.
- The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.
See the full eligibility criteria
- 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...
- 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.
- Severe intolerance or allergy to oral vancomycin or fidaxomicin.
- The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment 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.
- 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.
- 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 consent without a healthcare proxy.
- Lack of health insurance.
- Anticipated transfer to a site not involved in this trial, or to a palliative care ward
- Patient-declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.