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Extended Vancomycin Treatment for Clostridium Difficile Infection (TAPER-V Trial)
TAPER-V Trial Summary
This trial will help doctors learn if extending the initial treatment for CDI from 14 to 28 days with a tapering dose of vancomycin will reduce the risk of recurrence.
TAPER-V Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTAPER-V Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TAPER-V Trial Design
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Who is running the clinical trial?
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- My condition did not improve by day 10 of treatment.I am currently being treated for CDI with specific medications or procedures.You are currently breastfeeding.I have had part or all of my colon removed.My toxic megacolon symptoms have not improved after 10 days.I have sensorineural hearing loss not caused by aging, loud noise, Menière's disease, MS, syphilis, viral infections, autoimmune disorders, medication, or unexplained sudden loss.I am an adult being treated for my first or second bout of C. diff infection.I have had 3 or more episodes of diarrhea in 24 hours and tested positive for CDI.I am unable to make my own healthcare decisions and have someone appointed to do so.I cannot be reached reliably for follow-up.You have a strong allergic reaction or cannot tolerate taking vancomycin by mouth.I tested positive and have less than three bowel movements, but had ileus or pseudomembranous colitis seen on a colonoscopy.I have had C. difficile more than twice in the past 5 years.I cannot attend follow-up appointments.I am not expected to live more than 3 months due to another illness.
- Group 1: Control: Placebo
- Group 2: Intervention: Extended vancomycin regimen
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA condone the use of extended vancomycin therapy?
"There is some evidence from past clinical trials to support the safety of this vancomycin regimen, so it was given a score of 3."
Are there any restrictions on who can take part in this research?
"552 individuals with clostridium infections will be able to take part in this trial, provided they are between 18-100 years old. Most importantly, candidates should meet the following criteria: having less than three bowel movements but still testing positive for the infection, presenting ileus or pseudomembranous colitis during colonoscopy, being diagnosed with CDI through a positive PCR test for toxin gene and/or detection of toxin by EIA or CCA along with three or more episodes of diarrhea within 24 hours. In other words, any adult patient who has had their first episode or recurrence of CDI is"
How many people are enrolled in this research project?
"In order to begin the trial, 552 patients must enroll and meet the specified inclusion criteria. Patients can go to University Health Network in Toronto or Sunnybrook Health Science Centre in Montreal to participate."
Are there any subjects needed for this research project?
"Yes, this trial is still open and actively recruiting patients as of September 30th, 2022. This information can be found on the clinicaltrials.gov website, which also reports that the trial was first posted on November 19th, 2020."
Are there comparable studies to this one involving Intervention: Extended vancomycin regimen?
"Currently, there are 60 active clinical trials researching the efficacy of extended vancomycin regimens. 6 of those trials are in Phase 3. While many of the trials for this treatment are based in São Paulo, SP, there are 320 total locations running studies on this topic."
Are there many different medical clinics running this study in the city?
"To try and make the trial more accessible to those who wish to participate, it is being run out of 5 sites. These include locations in Toronto, Montreal and a few other surrounding areas."
Can people over the age of 80 participate in this research?
"The age requirements to participate in this clinical trial are between 18-100 years old. Out of the 922 total trials, 222 are for patients younger than 18 and 700 are for senior citizens."
When is it most common to see an Intervention: Extended vancomycin regimen prescribed?
"The listed infections - staphylococcal infections, infection caused by staphylococci, and enterocolitis caused by staphylococcus aureus - can all be treated by the extended vancomycin regimen."
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