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
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Annandale, Virginia 22003
?
mi
from
Annandale, VA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13123 East 16th Avenue
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06610
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Burr Ridge, Illinois 60527
?
mi
from
Burr Ridge, IL
Click here to add this to my saved trials
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
Chapel Hill, North Carolina
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60061
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Detroit, Michigan
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Grafton, Wisconsin 53024
?
mi
from
Grafton, WI
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kinston, North Carolina 28501
?
mi
from
Kinston, NC
Click here to add this to my saved trials
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Maywood, Illinois 60153
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Morristown, New Jersey
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Murrieta, California 92563
?
mi
from
Murrieta, CA
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
3200 West End Avenue
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10001
?
mi
from
New York, NY
Click here to add this to my saved trials
Oakland, California 94607
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Ogden, Utah 84403
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Pinehurst, North Carolina 28374
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Poland, Ohio 44514
?
mi
from
Poland, OH
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02904
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rochester, Minnesota 55902
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Saint Paul, Minnesota 55130
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94121
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85258
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66128
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
Somers Point, New Jersey 08244
?
mi
from
Somers Point, NJ
Click here to add this to my saved trials
Tampa, Florida 33603
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
West Des Moines, Iowa 50265
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials