Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Recurrence

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first recurrence of Clostridioides difficile infection (rCDI).

Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days, min 7) followed by FMT by oral capsules (one FMT, i.e. 15 FMT capsules given on 2 consecutive days, and followed by a mandatory 2nd FMT in severe rCDI, or by a 2nd FMT only in case of persisting symptoms in non-severe rCDI).

Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benoit Guery
• Treatments: Fidaxomicin; Vancomycin

Criteria

Inclusion Criteria:

1. Adults (≥18 years old) at the time of informed consent

2. Informed consent signature

3. Medical record documentation of first recurrence of CDI defined as:

1. Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a clinical picture of CDI combined with a CDI test performed according to CDI diagnosis ESCMID guidelines

2. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI test performed according to CDI diagnosis ESCMID guidelines, with a mandatory toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea.

4. No multiple episodes (more than one recurrence) of CDI that occurred within 3 last months.

5. Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.

6. Willing and able to have FMT by capsule

Exclusion Criteria:

1. Complicated CDI (at least one of the following signs or symptoms are present and related to CDI: hypotension requiring vasopressors, intensive care unit admission for a complication of CDI, ileus leading to placement of nasogastric tube, toxic megacolon, colonic perforation, colectomy or colostomy)(2),

2. Prior FMT within 6 months of randomization,

3. Prior colectomy, colostomy, ileostomy, or gastrectomy.

4. Metronidazole already given for the treatment of the first rCDI for more than 3 days,

5. Need for continued non-anti-CDI systemic antibiotics,

6. Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks,

7. Other infectious causes of diarrhea beyond CDI,

8. Inflammatory bowel disease,

9. Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,

10. Known hypersensitivity to vancomycin or fidaxomicin,

11. Pregnant/lactating women,

12. Estimated patient's life expectancy of less than 10 weeks,

13. Inability to follow protocol study procedures,

14. Inability to give informed consent,

15. Any condition or medications that will put the participant at greater risk from FMT according to the investigator,

16. Severely immunocompromised