Bezlotoxumab Versus FMT for Multiple Recurrent CDI (NCT05077085) | Clinical Trial Compass
WithdrawnPhase 4
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
Stopped: Withdrawn
Netherlands0Started 2022-01
Plain-language summary
The objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B includes FMT as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. A secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-90 years old
* diarrhea (3 or more unformed stools per 24h for two consecutive days; or \>= 8 unformed stools per 48h) XML File Identifier: KqQEbBLRYEZjGgsIl5GcI+NXCyM= Page 10/22
* positive PCR test for toxin A/B genes and/or positive toxin EIA for current and previous episodes (low PCR cycle threshold value when only PCR performed)
* a minimum of two prior CDI episodes
* previous episode is maximum of 3 months prior to the current episode
* the current episode responds well to Standard of Care treatment (vancomycin or fidaxomicin orally).
* Assessment of the severity of the disease will be performed according to the ESCMID recommendations.
* Both mild and severe CDI will be included
Exclusion Criteria:
* Severe complicated CDI, i.e presence of: hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, bowel perforation, or any fulminant course of disease.
* ICU admission for underlying disease
* pregnancy or current desire for pregnancy
* breastfeeding
* (prolonged) use of antibiotics (other than for treatment of CDI) during the study period or directly after the intervention
* previous use of bezlotoxumab or fecal microbiota transplantation
* a history of underlying congestive heart failure (potential safety signal phase-III trail bezlotoxumab).
* Diagnosis of inflammatory bowel disease in medical history.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global cure of the treatment strategy
Timeframe: 12 weeks (after rescue therapy if applicable)