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

Use our guide to learn which trials are right for you!

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
Annandale, Virginia 22003
2317
mi
from 98109
Annandale, VA
Click here to add this to my saved trials
2176
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
13123 East 16th Avenue
Aurora, Colorado 80045
1027
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland
2320
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35205
2080
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06610
2424
mi
from 98109
Bridgeport, CT
Click here to add this to my saved trials
2404
mi
from 98109
Bronx, NY
Click here to add this to my saved trials
Burr Ridge, Illinois 60527
1723
mi
from 98109
Burr Ridge, IL
Click here to add this to my saved trials
Butte, Montana 59701
477
mi
from 98109
Butte, MT
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from 98109
Calgary,
Click here to add this to my saved trials
Chapel Hill, North Carolina
2337
mi
from 98109
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
2285
mi
from 98109
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60061
1696
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
1966
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
Detroit, Michigan
1933
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
Evanston, Illinois 60201
1725
mi
from 98109
Evanston, IL
Click here to add this to my saved trials
Grafton, Wisconsin 53024
1678
mi
from 98109
Grafton, WI
Click here to add this to my saved trials
Hamden, Connecticut 06518
2429
mi
from 98109
Hamden, CT
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
577
mi
from 98109
Idaho Falls, ID
Click here to add this to my saved trials
Indianapolis, Indiana 46260
1868
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida
2452
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
Kinston, North Carolina 28501
2431
mi
from 98109
Kinston, NC
Click here to add this to my saved trials
Lexington, Kentucky 40536
2005
mi
from 98109
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90036
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Maywood, Illinois 60153
1723
mi
from 98109
Maywood, IL
Click here to add this to my saved trials
Morristown, New Jersey
2399
mi
from 98109
Morristown, NJ
Click here to add this to my saved trials
Murrieta, California 92563
1008
mi
from 98109
Murrieta, CA
Click here to add this to my saved trials
Naples, Florida 34102
2643
mi
from 98109
Naples, FL
Click here to add this to my saved trials
3200 West End Avenue
Nashville, Tennessee 37203
1970
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
2099
mi
from 98109
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10001
2401
mi
from 98109
New York, NY
Click here to add this to my saved trials
Oakland, California 94607
678
mi
from 98109
Oakland, CA
Click here to add this to my saved trials
Ogden, Utah 84403
675
mi
from 98109
Ogden, UT
Click here to add this to my saved trials
Pinehurst, North Carolina 28374
2221
mi
from 98109
Pinehurst, NC
Click here to add this to my saved trials
Pinellas Park, Florida 33781
2521
mi
from 98109
Pinellas Park, FL
Click here to add this to my saved trials
Poland, Ohio 44514
2085
mi
from 98109
Poland, OH
Click here to add this to my saved trials
Portland, Oregon 97210
145
mi
from 98109
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02904
2485
mi
from 98109
Providence, RI
Click here to add this to my saved trials
Rochester, Minnesota 55902
1450
mi
from 98109
Rochester, MN
Click here to add this to my saved trials
Royal Oak, Michigan 48073
1924
mi
from 98109
Royal Oak, MI
Click here to add this to my saved trials
Saint Paul, Minnesota 55130
1400
mi
from 98109
Saint Paul, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84124
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
1787
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94121
680
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85258
1113
mi
from 98109
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington
2
mi
from 98109
Seattle, WA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66128
1500
mi
from 98109
Shawnee Mission, KS
Click here to add this to my saved trials
Somers Point, New Jersey 08244
2421
mi
from 98109
Somers Point, NJ
Click here to add this to my saved trials
Tampa, Florida 33603
2525
mi
from 98109
Tampa, FL
Click here to add this to my saved trials
Washington, District of Columbia
2322
mi
from 98109
Washington,
Click here to add this to my saved trials
West Des Moines, Iowa 50265
1459
mi
from 98109
West Des Moines, IA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2272
mi
from 98109
Winston-Salem, NC
Click here to add this to my saved trials