A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

ICD-01

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 increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with Fidaxomicin, in 66 patients with primary or r-CDI.

2021-10-29

2023-11-15

2023-11-15

Completed

Early phase I

93

Inclusion Criteria: 1. Patients of both genders, over 18 years. 2. Patients that undergo an episode of CD infection (either the first episode or subsequent recurrences). 3. Presence of an episode of diarrhea defined as ≥3 stools/24 hours, at the beginning of the episode. 4. 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 Criteria: 1. Previous faecal microbiota transfer. 2. Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function. 3. Absolute neutrophil count \<500 cells /μL at the time of the enrollment in the study. 4. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study. 5. Active treatment with bile acid sequestrants (for instance: cholestyramine). 6. 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. 7. Swallowing dysfunction or no oral motor coordination. 8. Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness. 9. History of significant medical conditions that, in the opinion of the investigator, would not allow an adequate evaluation or follow-up of the patient.

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2024-01-12