Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection



Status:Enrolling by invitation
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:May 1, 2018
End Date:May 1, 2020

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PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

This is an open-label extension of CDI-001 (subsequently referred to as PRISM 3), and is
evaluating the safety and efficacy in reducing recurrence of CDI in adults who had a CDI
recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are
experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility
criteria will be eligible to be enrolled in the extension study and administered CP101.

Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects
will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following
receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post
treatment, and all subjects will continue to be followed for an additional 16 weeks for
safety and recurrence of CDI.


1. Ability to provide written informed consent;

2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101
or placebo, and have completed their PRISM 3 end of study visit.

3. An outpatient prior to Treatment

4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI
episode, has had an adequate clinical response, and has completed a washout period.

Exclusion Criteria:

1. Pregnant, breast-feeding, or considering becoming pregnant during the study

2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's
disease and ulcerative colitis)

3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome

4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days
prior to consent or planned during the 8 weeks following Randomization

5. Prior fecal transplant for any condition, regardless of route of administration in the
last year or plans to undergo during the study

6. Major intra-abdominal surgery within the past 60 days prior to Screening

7. Admitted to, or expected to be admitted to an intensive care unit for any medical
reason. Note: Residents of long term care facilities are eligible study entry

8. History of total colectomy/ileostomy or bariatric surgery

9. Planned hospitalization or invasive surgery during the study

10. Severe acute illness unrelated to CDI
We found this trial at
54
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485
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Bronx, NY
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Annandale, Virginia 22003
320
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Annandale, VA
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432
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Atlanta, GA
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13123 East 16th Avenue
Aurora, Colorado 80045
1154
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Aurora, CO
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Baltimore, Maryland
336
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Baltimore, MD
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Birmingham, Alabama 35205
493
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Birmingham, AL
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Boston, Massachusetts 02115
643
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Boston, MA
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Bridgeport, Connecticut 06610
521
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Bridgeport, CT
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Burr Ridge, Illinois 60527
283
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Burr Ridge, IL
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Butte, Montana 59701
1537
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Butte, MT
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Calgary, Alberta
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Calgary,
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Chapel Hill, North Carolina
353
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Chapel Hill, NC
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Charlottesville, Virginia 22908
278
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Charlottesville, VA
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Chicago, Illinois 60061
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Chicago, IL
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Cincinnati, Ohio 45219
98
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Cincinnati, OH
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Detroit, Michigan
163
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Detroit, MI
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Evanston, Illinois 60201
282
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Evanston, IL
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Grafton, Wisconsin 53024
344
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Hamden, Connecticut 06518
538
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Idaho Falls, Idaho 83404
1506
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Indianapolis, Indiana 46260
166
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Indianapolis, IN
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Jacksonville, Florida
669
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Jacksonville, FL
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Kinston, North Carolina 28501
440
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Kinston, NC
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Lexington, Kentucky 40536
155
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Lexington, KY
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Los Angeles, California 90036
1972
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Maywood, Illinois 60153
284
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Maywood, IL
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Morristown, New Jersey
463
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Murrieta, California 92563
1931
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Naples, Florida 34102
957
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Naples, FL
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3200 West End Avenue
Nashville, Tennessee 37203
335
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New Orleans, Louisiana 70115
797
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New York, New York 10001
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Oakland, California 94607
2100
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Ogden, Utah 84403
1514
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Pinehurst, North Carolina 28374
294
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Pinehurst, NC
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Pinellas Park, Florida 33781
837
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Poland, Ohio 44514
146
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Poland, OH
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Portland, Oregon 97210
2029
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Providence, Rhode Island 02904
619
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Rochester, Minnesota 55902
559
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Royal Oak, Michigan 48073
174
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Royal Oak, MI
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Saint Paul, Minnesota 55130
617
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Salt Lake City, Utah 84124
1513
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San Antonio, Texas 78229
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San Diego, California
1951
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San Francisco, California 94121
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Scottsdale, Arizona 85258
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Seattle, Washington
2006
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Shawnee Mission, Kansas 66128
626
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Somers Point, New Jersey 08244
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Tampa, Florida 33603
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Washington, District of Columbia
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West Des Moines, Iowa 50265
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Winston-Salem, North Carolina 27103
307
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