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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West Des Moines, Iowa 50265
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Annandale, Virginia 22003
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Atlanta, GA
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13123 East 16th Avenue
Aurora, Colorado 80045
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Baltimore, Maryland
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Birmingham, Alabama 35205
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Boston, Massachusetts 02115
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Bridgeport, Connecticut 06610
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Bridgeport, CT
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Bronx, NY
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Burr Ridge, Illinois 60527
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Butte, Montana 59701
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Calgary, Alberta
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Chapel Hill, North Carolina
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Charlottesville, Virginia 22908
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Chicago, Illinois 60061
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Cincinnati, Ohio 45219
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Detroit, Michigan
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Evanston, Illinois 60201
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Grafton, Wisconsin 53024
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Hamden, Connecticut 06518
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46260
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Jacksonville, Florida
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Kinston, North Carolina 28501
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Lexington, Kentucky 40536
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Los Angeles, California 90036
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Maywood, Illinois 60153
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Morristown, New Jersey
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Murrieta, California 92563
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Naples, Florida 34102
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3200 West End Avenue
Nashville, Tennessee 37203
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New Orleans, Louisiana 70115
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New York, New York 10001
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Oakland, California 94607
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Ogden, Utah 84403
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Pinehurst, North Carolina 28374
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Pinellas Park, Florida 33781
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Poland, Ohio 44514
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Portland, Oregon 97210
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Providence, Rhode Island 02904
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Rochester, Minnesota 55902
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Royal Oak, Michigan 48073
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Saint Paul, Minnesota 55130
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Salt Lake City, Utah 84124
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San Antonio, Texas 78229
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San Diego, California
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San Francisco, California 94121
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Scottsdale, Arizona 85258
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Seattle, Washington
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Shawnee Mission, Kansas 66128
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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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Winston-Salem, North Carolina 27103
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