Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Public ClinicalTrials.gov record NCT03244644. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03244644
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Interventions
- RBX2660 Drug
- Placebo Drug
- Open label RBX2660 (only for confirmed CDI recurrence) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2017 (Actual)
- Primary completion
- Apr 2, 2020 (Actual)
- Completion
- Aug 3, 2020 (Actual)
- Last update posted
- Jul 10, 2024
2017 – 2020
United States locations
- U.S. sites
- 60
- U.S. states
- 35
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Athens | Athens | Alabama | 35611 | — |
| Dothan | Dothan | Alabama | 36305 | — |
| Phoenix | Phoenix | Arizona | 85054 | — |
| North Little Rock | North Little Rock | Arkansas | 72117 | — |
| Lancaster | Lancaster | California | 93534 | — |
| Los Angeles | Los Angeles | California | 90095 | — |
| Oxnard | Oxnard | California | 93030 | — |
| Sacramento | Sacramento | California | 95817 | — |
| Aurora | Aurora | Colorado | 80045 | — |
| Hamden | Hamden | Connecticut | 06518 | — |
| Gainesville | Gainesville | Florida | 32610 | — |
| Jacksonville | Jacksonville | Florida | 32224 | — |
| Miami | Miami | Florida | 33176 | — |
| Port Orange | Port Orange | Florida | 32127 | — |
| Atlanta | Atlanta | Georgia | 30322 | — |
| Atlanta | Atlanta | Georgia | 30342 | — |
| Idaho Falls | Idaho Falls | Idaho | 83404 | — |
| Gurnee | Gurnee | Illinois | 60031 | — |
| Highland Park | Highland Park | Illinois | 60035 | — |
| Maywood | Maywood | Illinois | 60153 | — |
| Lafayette | Lafayette | Indiana | 47904 | — |
| Topeka | Topeka | Kansas | 66606 | — |
| Wichita | Wichita | Kansas | 67214 | — |
| Lexington | Lexington | Kentucky | 40536 | — |
| New Orleans | New Orleans | Louisiana | 70121 | — |
| Shreveport | Shreveport | Louisiana | 71105 | — |
| Boston | Boston | Massachusetts | 02114 | — |
| Detroit | Detroit | Michigan | 48202 | — |
| Plymouth | Plymouth | Minnesota | 55446 | — |
| Rochester | Rochester | Minnesota | 55902 | — |
| St. Louis | St Louis | Missouri | 63110 | — |
| Omaha | Omaha | Nebraska | 68198-4031 | — |
| Omaha | Omaha | Nebraska | 68198 | — |
| Las Vegas | Las Vegas | Nevada | 89106 | — |
| Teaneck | Teaneck | New Jersey | 07666 | — |
| New York | New York | New York | 10016 | — |
| North Massapequa | North Massapequa | New York | 11758 | — |
| Rochester | Rochester | New York | 14618 | — |
| Durham | Durham | North Carolina | 27710 | — |
| Greenville | Greenville | North Carolina | 27834 | — |
| Wilmington | Wilmington | North Carolina | 28401 | — |
| Fargo | Fargo | North Dakota | 58102 | — |
| Toledo | Toledo | Ohio | 43608 | — |
| Portland | Portland | Oregon | 97701 | — |
| Flourtown | Flourtown | Pennsylvania | 19031 | — |
| Philadelphia | Philadelphia | Pennsylvania | 19102 | — |
| Philadelphia | Philadelphia | Pennsylvania | 19107-5244 | — |
| Uniontown | Uniontown | Pennsylvania | 15401 | — |
| Wyomissing | Wyomissing | Pennsylvania | 19610 | — |
| Charleston | Charleston | South Carolina | 29425 | — |
| Rapid City | Rapid City | South Dakota | 57701 | — |
| Hixson | Hixson | Tennessee | 37434 | — |
| Dallas | Dallas | Texas | 75246 | — |
| Houston | Houston | Texas | 77030 | — |
| West Jordan | West Jordan | Utah | 84088 | — |
| Springfield | Springfield | Virginia | 22150 | — |
| Winchester | Winchester | Virginia | 22601 | — |
| Seattle | Seattle | Washington | 98104 | — |
| Madison | Madison | Wisconsin | 53792 | — |
| Marshfield | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03244644, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2024 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03244644 live on ClinicalTrials.gov.