Phase
Condition
Gastroenteritis
Clostridium Difficile-associated Diarrhea
Treatment
RBX2660
Open label RBX2660 (only for confirmed CDI recurrence)
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥ 18 years old.
Medical record documentation of recurrent CDI per the study definition, thatincludes either: a) at least one recurrence after a primary episode and hascompleted at least one round of standard-of-care oral antibiotic therapy or b) hashad at least two episodes of severe CDI resulting in hospitalization within the lastyear.
A positive stool test for the presence of toxigenic C. difficile within 30 daysprior to or on the date of enrollment.
Is currently taking or was just prescribed antibiotics to control CDI relateddiarrhea at the time of enrollment.
[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]
Exclusion
Exclusion Criteria:
Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDItreatment.
Previous fecal transplant
History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn'sdisease, or microscopic colitis.
Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
Compromised immune system (e.g. immunosuppressed due to a medical condition ormedication; current or recent (< 90 days) treatment with chemotherapy)
An absolute neutrophil count of <1000 cells/µL during screening.
Pregnant, breastfeeding, or intends to become pregnant during study participation.
Study Design
Study Description
Connect with a study center
Calgary
Calgary, Alberta T2N2T9
CanadaSite Not Available
Edmonton
Edmonton, Alberta TG2X8
CanadaSite Not Available
Vancouver
Vancouver, British Columba V5Z1M9
CanadaSite Not Available
Victoria
Victoria, British Columbia BC V8R 1J8
CanadaSite Not Available
Fredericton
Fredericton, New Brunswick E3B 4R3
CanadaSite Not Available
Moncton
Moncton, New Brunswick E1C628
CanadaSite Not Available
Athens
Athens, Alabama 35611
United StatesSite Not Available
Dothan
Dothan, Alabama 36305
United StatesSite Not Available
Phoenix
Phoenix, Arizona 85054
United StatesSite Not Available
North Little Rock
North Little Rock, Arkansas 72117
United StatesSite Not Available
Lancaster
Lancaster, California 93534
United StatesSite Not Available
Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
Oxnard
Oxnard, California 93030
United StatesSite Not Available
Sacramento
Sacramento, California 95817
United StatesSite Not Available
Aurora
Aurora, Colorado 80045
United StatesSite Not Available
Hamden
Hamden, Connecticut 06518
United StatesSite Not Available
Gainesville
Gainesville, Florida 32610
United StatesSite Not Available
Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Miami
Miami, Florida 33176
United StatesSite Not Available
Port Orange
Port Orange, Florida 32127
United StatesSite Not Available
Atlanta
Atlanta, Georgia 30322
United StatesSite Not Available
Idaho Falls
Idaho Falls, Idaho 83404
United StatesSite Not Available
Gurnee
Gurnee, Illinois 60031
United StatesSite Not Available
Highland Park
Highland Park, Illinois 60035
United StatesSite Not Available
Maywood
Maywood, Illinois 60153
United StatesSite Not Available
Lafayette
Lafayette, Indiana 47904
United StatesSite Not Available
Topeka
Topeka, Kansas 66606
United StatesSite Not Available
Wichita
Wichita, Kansas 67214
United StatesSite Not Available
Lexington
Lexington, Kentucky 40536
United StatesSite Not Available
New Orleans
New Orleans, Louisiana 70121
United StatesSite Not Available
Shreveport
Shreveport, Louisiana 71105
United StatesSite Not Available
Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Detroit
Detroit, Michigan 48202
United StatesSite Not Available
Plymouth
Plymouth, Minnesota 55446
United StatesSite Not Available
St. Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Omaha
Omaha, Nebraska 68198-4031
United StatesSite Not Available
Las Vegas
Las Vegas, Nevada 89106
United StatesSite Not Available
Teaneck
Teaneck, New Jersey 07666
United StatesSite Not Available
New York
New York, New York 10016
United StatesSite Not Available
North Massapequa
North Massapequa, New York 11758
United StatesSite Not Available
Rochester
Rochester, New York 14618
United StatesSite Not Available
Durham
Durham, North Carolina 27710
United StatesSite Not Available
Greenville
Greenville, North Carolina 27834
United StatesSite Not Available
Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Fargo
Fargo, North Dakota 58102
United StatesSite Not Available
Lima
Lima, Ohio 45801
United StatesSite Not Available
Toledo
Toledo, Ohio 43608
United StatesSite Not Available
Portland
Portland, Oregon 97701
United StatesSite Not Available
Flourtown
Flourtown, Pennsylvania 19031
United StatesSite Not Available
Philadelphia
Philadelphia, Pennsylvania 19102
United StatesSite Not Available
Uniontown
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Wyomissing
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Charleston
Charleston, South Carolina 29425
United StatesSite Not Available
Rapid City
Rapid City, South Dakota 57701
United StatesSite Not Available
Hixson
Hixson, Tennessee 37434
United StatesSite Not Available
Dallas
Dallas, Texas 75246
United StatesSite Not Available
Houston
Houston, Texas 77030
United StatesSite Not Available
West Jordan
West Jordan, Utah 84088
United StatesSite Not Available
Springfield
Springfield, Virginia 22150
United StatesSite Not Available
Winchester
Winchester, Virginia 22601
United StatesSite Not Available
Seattle
Seattle, Washington 98104
United StatesSite Not Available
Madison
Madison, Wisconsin 53792
United StatesSite Not Available
Marshfield
Marshfield, Wisconsin 54449
United StatesSite Not Available
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