Status:
COMPLETED
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Lead Sponsor:
Mikrobiomik Healthcare Company S.L.
Conditions:
Recurrent Clostridium Difficile Infection
Primary Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increas...
Detailed Description
This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered an episode of Clostridioides difficile infection (either the first episode or subsequent recur...
Eligibility Criteria
Inclusion
- Patients of both genders, over 18 years.
- Patients that undergo an episode of CD infection (either the first episode or subsequent recurrences).
- Presence of an episode of diarrhea defined as ≥3 stools/24 hours, at the beginning of the episode.
- Confirmation of the presence of CD toxin A and/or B in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin/s producing genes, at the start of the episode that is going to be treated in the clinical trial (the toxin test must be positive within 7 days prior to the enrolment of the patient in the trial).
Exclusion
- Previous faecal microbiota transfer.
- Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function.
- Absolute neutrophil count \<500 cells /μL at the time of the enrollment in the study.
- Pregnancy, breastfeeding, or pregnancy intentions over the course of the study.
- Active treatment with bile acid sequestrants (for instance: cholestyramine).
- Positive patients for the human immunodeficiency virus (HIV) except those with lymphocytes T CD4 count \> 200 cells/μL and viral load less than 20 copies.
- Swallowing dysfunction or no oral motor coordination.
- Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness.
- History of significant medical conditions that, in the opinion of the investigator, would not allow an adequate evaluation or follow-up of the patient.
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05201079
Start Date
October 29 2021
End Date
November 15 2023
Last Update
March 25 2025
Active Locations (21)
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1
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
2
Hospital General Universitario de Alicante
Alicante, Spain, 03010
3
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
4
Hospital Quirónsalud Barcelona
Barcelona, Spain, 08023