RecruitingPHASE3INTERVENTIONAL

Vancomycin Taper to Prevent Recurrent Clostridioides Difficile

This study is investigating new ways to treat a common gut infection called Clostridioides difficile, or C. diff. This infection can cause severe diarrhoea and often comes back, which can be very distressing and hard to treat. The research aims to find out if a specific way of taking the antibiotic vancomycin, known as a 'pulse and taper' treatment, is just as good as another antibiotic called fidaxomicin. Both treatments are used to stop C. diff from returning within 56 days. Currently, fidaxomicin is expensive and not always available. If the special vancomycin treatment works just as well, it could offer a more accessible and affordable option for many patients in the UK who suffer from this challenging infection.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

500

Start

24 Apr 2026

Estimated completion

01 Nov 2030

Clostridia Difficile Colitis

What is this study about?

This research is looking into better ways to treat a gut infection called Clostridioides difficile, often shortened to C. diff. This infection can cause unpleasant and sometimes severe diarrhoea. For many people, one of the biggest problems with C. diff is that it often comes back, even after treatment. These returning infections can be very difficult to manage and can have a big impact on a person's health and daily life.

The main goal of this study is to compare two different ways of treating C. diff to see which is best at preventing it from coming back. One treatment involves taking an antibiotic called vancomycin in a special way, where the dose is slowly reduced over time (this is called a 'pulse and taper'). The other treatment uses a different antibiotic called fidaxomicin. Doctors want to see if the vancomycin taper treatment works just as well as fidaxomicin in stoping the infection from returning within 56 days.

This study is really important because fidaxomicin, while effective, can be very expensive and not always easy to get. If the vancomycin taper treatment is found to be just as good, it could give doctors another effective and more accessible option for treating C. diff and preventing it from coming back, helping more people get better and stay better.

Key takeaways

Tests two common antibiotics for C. diff: vancomycin (special dose reduction) and fidaxomicin.
Aims to prevent C. diff from returning within 56 days.
Could provide a more affordable and accessible treatment option.
Focuses on people with their first infection or first time the infection has come back.
Participation involves taking medication and follow-up appointments.

Who may be eligible?

This study is looking for adults aged 18 or over who are either currently in hospital or being seen as an outpatient for a C. diff infection. To join, you must have your first C. diff infection or your first time the infection has come back within 56 days. The infection needs to be confirmed by a lab test, and you must also be experiencing certain symptoms like having three or more loose stools in under 24 hours for more than a day, or have specific findings during a colonoscopy or other tests.

Because fidaxomicin is expensive, there are extra rules about who can get it within the study. You might be included if you are 65 or older, have a weakened immune system, if this is your second C. diff infection within 12 weeks, or if you've had C. diff come back multiple times (at least twice).

You won't be able to join the study if you are already getting certain treatments for C. diff, such as a stool transplant or specific new gut-related therapies. Other reasons for not joining include being unable to swallow medicines, having had your large bowel completely removed, or having a severe allergy to vancomycin or fidaxomicin. You also can't take part if you're expected to die within 3 months from another illness, have a very severe C. diff infection requiring intensive care, or if you've already received a substantial amount of vancomycin or fidaxomicin for your current infection. Pregnant or breastfeeding individuals are also not eligible due to limited information on the effects of fidaxomicin in these situations.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed C. diff infection (first time or first recurrence)?
Can you take medicines by mouth?
Are you currently pregnant or breastfeeding?
Are you receiving other specific C. diff treatments (like a stool transplant)?
Do you have very severe C. diff that is life-threatening?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either a special vancomycin treatment plan (where the dose is slowly reduced) or a 10-day course of fidaxomicin. Both medicines are taken by mouth. You will then be carefully monitored to see if your C. diff infection comes back within a period of 56 days. This will involve regular check-ups and possibly stool sample tests. The total duration of your active participation will depend on the treatment schedule and follow-up, but the main goal is to track your progress for about two months after starting treatment to see if the infection returns.

Potential risks and benefits

Taking part in this study might offer you the benefit of receiving one of the leading treatments for C. diff under careful medical supervision, potentially helping to prevent the infection from returning. As with any medication, there are potential risks, such as side effects from the antibiotics, which your doctor will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is C. diff?

C. diff is a germ in your gut that can cause bad diarrhoea and other digestive problems.

Why is this study important?

It's important because it aims to find a more accessible and affordable way to stop C. diff infections from coming back.

What are the treatments being tested?

We are comparing a special way of taking vancomycin (a 'taper') with another medicine called fidaxomicin.

How long will I be involved in the study?

The study will track your progress for about 56 days after you start treatment to see if the infection returns.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your normal medical care.

How to find out more

Connor Prosty, MD

connor.prosty@mail.mcgill.ca 514-934-1934 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.