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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

NCT03244644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2024-07-10

Study results available
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Summary

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence 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 Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

Conditions

  • Clostridium Difficile Infection (CDI)

Interventions

DRUG

RBX2660

RBX2660 is a rectally administered microbiota suspension

DRUG

Placebo

Placebo is normal saline solution administered rectally

DRUG

Open label RBX2660 (only for confirmed CDI recurrence)

RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660

Sponsors & Collaborators

  • Rebiotix Inc.

    lead INDUSTRY

Principal Investigators

  • Teena Chopra, M.D., M.P.H. · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2020-04-02
Completion
2020-08-03
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244644 on ClinicalTrials.gov