Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

Phase 3

Completed

• Conditions: Infection; Clostridium Difficile Infection; Communicable Diseases
• Interventions: Drug: RBX2660

• Registration Number: NCT03931941
• Lead Sponsor: Rebiotix Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Study Start: 2019-07-30
• Status Verified: 2023-04
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Results First Submitted: 2024-07-12
• Results First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Results First Posted: 2024-08-07
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 793

Inclusion Criteria

1. ≥ 18 years old.
2. Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
3. 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.]

Exclusion Criteria

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/mm^3 during Screening.
7. An absolute neutrophil count of <1000 cells/µL during Screening.
8. Pregnant, breastfeeding, or intends to become pregnant during study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	RBX2660	RBX2660 is an enema of a microbiota suspension

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.	Up to 6 months after last study treatment.	Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).

Secondary Outcome Measures

Name	Time	Method
Sustained Clinical Response Through 6 Months After Treatment.	6 months after completing the study treatment	Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment.
Efficacy of RBX2660 Measured at 8 Weeks After Treatment.	8 weeks after completing the study treatment	The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.

Trial Locations

Locations (50)

Phoenix; 🇺🇸 Phoenix, Arizona, United States

North Little Rock; 🇺🇸 North Little Rock, Arkansas, United States

Oxnard; 🇺🇸 Oxnard, California, United States

Aurora; 🇺🇸 Aurora, Colorado, United States

Hamden; 🇺🇸 Hamden, Connecticut, United States

Gainesville; 🇺🇸 Gainesville, Florida, United States

Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Naples; 🇺🇸 Naples, Florida, United States

Orlando; 🇺🇸 Orlando, Florida, United States

Port Orange; 🇺🇸 Port Orange, Florida, United States

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