BridgeMD
New treatment option for Clostridioides Difficile Infection
Official title Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
ClinicalTrials.gov ID: NCT06306014
What this study is testing
What is EXL01?
EXL01 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clostridioides difficile infection.
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
- Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Adult patient ≥18 years of age
- ≥3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in stool by PCR or enzyme-linked...
- Age ≥70 years
- Chronic renal failure (haemodialysis or GFR\<60ml/min
- History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria
You likely can't join if
- Currently participating or has participated in a study with an investigational compound or device within 3 months prior to the first dose of the...
- Severe C. difficile infection severe (defined by the presence of a white blood cell count \>15×10⁹ cells/L or a body temperature \>38.5°C or \>50%...
- Refractory C. difficile infection defined as lack of response to well-conducted per os vancomycin or fidaxomicin treatment with ≥3 liquid stools per...
- Cirrhosis with Child C score
- Hospitalization in continuing care unit or intensive care unit
- Personal history of gastrointestinal resection other than appendectomy (gastrectomy, esophagectomy, colonic or small bowel resection, short small...
See the full eligibility criteria
- Adult patient ≥18 years of age
- ≥3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6...
- Age ≥70 years
- Chronic renal failure (haemodialysis or GFR\<60ml/min
- History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria
- ≥3 CDI in the last 12 months (including current episode)
- CDI associated with care defined as CDI occurring during hospitalisation (\<3 months)
- On current or planned vancomycin treatment per os
- Patient able to give free, informed and written consent
- Enrolled in compulsory national social security scheme
- Currently participating or has participated in a study with an investigational compound or device within 3 months prior to the first dose of the study intervention.
- Severe C. difficile infection severe (defined by the presence of a white blood cell count \>15×10⁹ cells/L or a body temperature \>38.5°C or \>50% increase in the patient's baseline creatinine related to CDI at the time...
- Refractory C. difficile infection defined as lack of response to well-conducted per os vancomycin or fidaxomicin treatment with ≥3 liquid stools per day after ≥5 days of treatment
- Cirrhosis with Child C score
- Hospitalization in continuing care unit or intensive care unit
- Personal history of gastrointestinal resection other than appendectomy (gastrectomy, esophagectomy, colonic or small bowel resection, short small bowel syndrome).
- Personal history of gastrointestinal resection resulting in chronic diarrhea (\>3 loose stools per day)
- Inflammatory bowel disease
- Proven uncontrolled celiac disease
- Current stoma (ileostomy or colostomy) or within the last 6 months, or any other intra-abdominal surgery within the 3 months prior to treatment
- major surgery or trauma ≤ 4 weeks before the start of treatment or, if \> 4 weeks ago, with an unresolved healing process that could affect the assessment or safety of the study treatment.
- Antibiotic therapy in progress or planned during the study for an infection other than CDI
- Surgery scheduled during the study requiring perioperative antibiotics.
- -Women without contraception\ , pregnant or breastfeeding women
- History of hypersensitivity to EXL01 and/or to any of its excipients (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and/or to soy or...
- History of hypersensitivity to vancomycin as mentioned in local prescribing information.
- Personal history of fecal microbiota transplantation \< 6 months
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection or unable to give consent
- Swallowing disorders making oral treatment impossible
- Participation in another treatment study within 3 months prior to inclusion. (Patients who have entered the follow-up phase of an treatment study may participate provided that more than 3 months have elapsed since the...
- Expected life expectancy of less than 6 months
- Presents a known psychiatric disorder that would interfere with adequate cooperation with study requirements.
- Regular use of illicit or recreational drugs that may interfere with the administration of the medication or the interpretation of the data
- History of chronic diarrhea (\> 3 watery stools per day for \> 4 weeks) not related to gastrointestinal infection.
- Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of study drug, the interpretation of study...
The study team makes the final eligibility decision.
Where it's taking place
- Annecy, France
- Clermont-Ferrand, France
- Grenoble, France
- Lille, France
- Lyon, France
- Marseille, France
- Paris, France
- Saint-Etienne, France
- Toulouse, France
- Valence, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Annecy, France; Clermont-Ferrand, France; Grenoble, France; Lille, France; Lyon, France; Marseille, France and 4 more location(s). 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.