Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

Official Title

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection

Details

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

Keywords

Clostridium Difficile Infection Infection Communicable Diseases C. Difficile Diarrhea Clostridium Difficile CDI FMT Fecal Microbiota Transplant Microbiota Restoration Therapy Diarrhea Microbial Suspension Fecal Transplant C Difficile Colitis Clostridium Difficile Associated Diarrhea C diff diarrhea C Difficile C diff Clostridium Infections Enterocolitis, Pseudomembranous RBX2660

Eligibility

You can join if…

Open to people ages 18 years and up

  1. ≥ 18 years old.
  2. Medical record documentation of either: a) recurrent CDI per the study definition, that includes at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy, b) or has had at least two episodes of severe CDI resulting in hospitalization.
  3. A positive stool test for the presence of toxigenic C. difficile or C. difficile toxin within 30 days prior to or on the date of enrollment.
  4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.

[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]

You CAN'T join if...

  1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  2. Requires systemic antibiotic therapy for a condition other than CDI.
  3. Fecal microbiota transplant (FMT) within the past 6 months.
  4. FMT with an associated serious adverse event related to the FMT product or procedure.
  5. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
  6. CD4 count <200/mm3 during Screening.
  7. An absolute neutrophil count of <1000 cells/µL during Screening.
  8. Pregnant, breastfeeding, or intends to become pregnant during study participation.

Locations

  • Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Sacramento not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rebiotix Inc.
ID
NCT03931941
Phase
Phase 3
Study Type
Interventional
Last Updated