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
sites
Morristown, New Jersey
2421
mi
from 91732
Morristown, NJ
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Annandale, Virginia 22003
2273
mi
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Annandale, VA
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1918
mi
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Atlanta, GA
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13123 East 16th Avenue
Aurora, Colorado 80045
825
mi
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Aurora, CO
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Baltimore, Maryland
2293
mi
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Baltimore, MD
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Birmingham, Alabama 35205
1785
mi
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Birmingham, AL
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Boston, Massachusetts 02115
2578
mi
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Boston, MA
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Bridgeport, Connecticut 06610
2472
mi
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Bridgeport, CT
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2439
mi
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Bronx, NY
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Burr Ridge, Illinois 60527
1714
mi
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Burr Ridge, IL
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Butte, Montana 59701
877
mi
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Butte, MT
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Calgary, Alberta
?
mi
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Calgary,
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Chapel Hill, North Carolina
2194
mi
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Chapel Hill, NC
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Charlottesville, Virginia 22908
2208
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Charlottesville, VA
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Chicago, Illinois 60061
1710
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Chicago, IL
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Cincinnati, Ohio 45219
1879
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Cincinnati, OH
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Detroit, Michigan
1966
mi
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Detroit, MI
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Evanston, Illinois 60201
1728
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Evanston, IL
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Grafton, Wisconsin 53024
1730
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Grafton, WI
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Hamden, Connecticut 06518
2486
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Hamden, CT
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Idaho Falls, Idaho 83404
721
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Idaho Falls, ID
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Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
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Jacksonville, Florida
2130
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Jacksonville, FL
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Kinston, North Carolina 28501
2282
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Kinston, NC
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Lexington, Kentucky 40536
1881
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Lexington, KY
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Los Angeles, California 90036
13
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Los Angeles, CA
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Maywood, Illinois 60153
1719
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Maywood, IL
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Murrieta, California 92563
58
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Murrieta, CA
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Naples, Florida 34102
2220
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Naples, FL
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3200 West End Avenue
Nashville, Tennessee 37203
1761
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Nashville, TN
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New Orleans, Louisiana 70115
1655
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New Orleans, LA
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New York, New York 10001
2433
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New York, NY
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Oakland, California 94607
352
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Oakland, CA
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Ogden, Utah 84403
593
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Ogden, UT
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Pinehurst, North Carolina 28374
2053
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Pinehurst, NC
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Pinellas Park, Florida 33781
2124
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Pinellas Park, FL
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Poland, Ohio 44514
2087
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Poland, OH
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Portland, Oregon 97210
830
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Portland, OR
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Providence, Rhode Island 02904
2562
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Providence, RI
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Rochester, Minnesota 55902
1524
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Rochester, MN
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Royal Oak, Michigan 48073
1962
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Royal Oak, MI
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Saint Paul, Minnesota 55130
1516
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Saint Paul, MN
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Salt Lake City, Utah 84124
570
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Salt Lake City, UT
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San Antonio, Texas 78229
1188
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San Antonio, TX
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San Diego, California
106
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San Diego, CA
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San Francisco, California 94121
355
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San Francisco, CA
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Scottsdale, Arizona 85258
352
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Scottsdale, AZ
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Seattle, Washington
961
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Seattle, WA
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Shawnee Mission, Kansas 66128
1333
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Shawnee Mission, KS
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Somers Point, New Jersey 08244
2409
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Somers Point, NJ
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Tampa, Florida 33603
2135
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Tampa, FL
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Washington, District of Columbia
2281
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Washington,
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West Des Moines, Iowa 50265
1416
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West Des Moines, IA
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Winston-Salem, North Carolina 27103
2122
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Winston-Salem, NC
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