A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cubist Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01598311
First received: May 10, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.


Condition Intervention Phase
Clostridium Difficile Infection
Drug: CB-183,315
Drug: oral vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of subjects with a clinical outcome of cure [ Time Frame: Two days after the last dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The clinical response over time based on the length of time it takes for the subjects to fail treatment, recur, die, or become lost to follow-up until Day 40 [ Time Frame: 30 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • The proportion of subjects who sustain a clinical outcome of cure until Day 50 [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 608
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CB-183,315 250mg/Surotomycin Drug: CB-183,315
oral, 250 mg bid for 10 days
Other Name: Surotomycin
Active Comparator: oral vancomycin, 125 mg Drug: oral vancomycin
oral, 125 mg qid for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

To be included in this study, participants must:

  • Sign a consent form;
  • Be older 18 or older and 90 or younger;
  • Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
  • Test positive for Clostridium difficile;
  • If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.

Participants will not be allowed into the study if they:

  • Have toxic megacolon and/or known small bowel ileus;
  • Have received treatment with intravenous immune globulin (IVIG)within the past 30 days;
  • Have received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
  • Have received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
  • Have received an investigational vaccine against C. difficile;
  • Have received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
  • Had more than 2 episodes of CDAD within 90 days;
  • Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months(this does not include appendectomy or cholecystectomy);
  • Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
  • Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
  • Are unable to discontinue opiate treatment unless on a stable dose;
  • Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
  • Had stool studies positive for pathogenic ova and/or parasites;
  • Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;
  • Have life-threatening illness at the time of enrollment;
  • Have poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
  • Have received an investigational drug or participated in any experimental procedure within 1 month;
  • Have HIV, a CD4 <200 cells/mm3 within 6 months of start of study therapy;
  • Anticipate that certain antibacterial therapy for a non-CDAD infection will be required for >7 days;
  • Are unable to discontinue Saccharomyces or similar probiotic;
  • Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
  • Are unable to comply with the protocol requirements;
  • Have any condition that, in the opinion of the Investigator, might interfere;
  • Are not expected to live for less than 8 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598311

Contacts
Contact: Mary E Sweeney 6102392764 mary.sweeney@incresearch.com
Contact: Michelle Mobilia 7818601081 michelle.mobilia@cubist.com

  Hide Study Locations
Locations
United States, Alabama
Withdrawn
Montgomery, Alabama, United States
United States, Arizona
Recruiting
Casa Grande, Arizona, United States
United States, California
Recruiting
Fountain Valley, California, United States
Withdrawn
Los Angeles, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Oceanside, California, United States
Active, not recruiting
Palm Springs, California, United States
Recruiting
Redding, California, United States
Recruiting
Sacramento, California, United States
Recruiting
San Francisco, California, United States
Withdrawn
Santa Ana, California, United States
Recruiting
Torrance, California, United States
United States, Colorado
Recruiting
Littleton, Colorado, United States
United States, Connecticut
Withdrawn
Hamden, Connecticut, United States
Recruiting
Hartford, Connecticut, United States
United States, Delaware
Recruiting
Newark, Delaware, United States
United States, District of Columbia
Withdrawn
Washington, District of Columbia, United States
United States, Florida
Active, not recruiting
Fort Pierce, Florida, United States
Recruiting
Maitland, Florida, United States
Recruiting
Orlando, Florida, United States
Recruiting
Pensacola, Florida, United States
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West Palm Beach, Florida, United States
Active, not recruiting
Weston, Florida, United States
United States, Georgia
Active, not recruiting
Marietta, Georgia, United States
United States, Idaho
Recruiting
Idaho Falls, Idaho, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Withdrawn
Chicago, Illinois, United States
United States, Iowa
Recruiting
Iowa City, Iowa, United States
United States, Kansas
Recruiting
Kansas City, Kansas, United States
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Wichita, Kansas, United States
United States, Kentucky
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Madisonville, Kentucky, United States
United States, Louisiana
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Baton Rouge, Louisiana, United States
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Eunice, Louisiana, United States
Recruiting
Metairie, Louisiana, United States
United States, Maine
Withdrawn
Auburn, Maine, United States
United States, Maryland
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Annapolis, Maryland, United States
Withdrawn
Chevy Chase, Maryland, United States
Recruiting
Columbia, Maryland, United States
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Towson, Maryland, United States
United States, Massachusetts
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
United States, Michigan
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Royal Oak, Michigan, United States
United States, Minnesota
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Chatfield, Minnesota, United States
Withdrawn
Minneapolis, Minnesota, United States
United States, Missouri
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St. Joseph, Missouri, United States
Recruiting
St. Louis, Missouri, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New Jersey
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Englewood, New Jersey, United States
Recruiting
Long Branch, New Jersey, United States
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Marlton, New Jersey, United States
Recruiting
Oakhurst, New Jersey, United States
United States, New York
Withdrawn
Albany, New York, United States
Withdrawn
Brooklyn, New York, United States
Recruiting
New York, New York, United States
Active, not recruiting
Valhalla, New York, United States
United States, North Carolina
Active, not recruiting
Durham, North Carolina, United States
Withdrawn
Flat Rock, North Carolina, United States
Active, not recruiting
Gastonia, North Carolina, United States
United States, North Dakota
Active, not recruiting
Fargo, North Dakota, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Recruiting
Cleveland, Ohio, United States
Recruiting
Lima, Ohio, United States
Active, not recruiting
Oregon, Ohio, United States
Withdrawn
Toledo, Ohio, United States
Recruiting
Toledo, Ohio, United States
United States, Oregon
Recruiting
Bend, Oregon, United States
Active, not recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Doylestown, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Withdrawn
Pittsburg, Pennsylvania, United States
Recruiting
Sayre, Pennsylvania, United States
Withdrawn
Sellersville, Pennsylvania, United States
United States, South Carolina
Withdrawn
Charleston, South Carolina, United States
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States
Recruiting
Jackson, Tennessee, United States
United States, Texas
Withdrawn
Dallas, Texas, United States
Recruiting
El Paso, Texas, United States
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Fort Worth, Texas, United States
Recruiting
Galveston, Texas, United States
Recruiting
Houston, Texas, United States
United States, Virginia
Recruiting
Lynchburg, Virginia, United States
Active, not recruiting
Virginia Beach, Virginia, United States
United States, Wisconsin
Withdrawn
Madison, Wisconsin, United States
Argentina
Active, not recruiting
Buenos Aires, Argentina
Withdrawn
Cordoba, Argentina
Active, not recruiting
Cordoba, Argentina
Australia, Australian Capital Territory
Recruiting
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Recruiting
Campbelltown, New South Wales, Australia
Recruiting
Concord, New South Wales, Australia
Recruiting
Penrith, New South Wales, Australia
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Westmead, New South Wales, Australia, A
Australia, Queensland
Recruiting
Cairns, Queensland, Australia
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Chermside, Queensland, Australia
Withdrawn
Nambour, Queensland, Australia
Australia, South Australia
Recruiting
Adelaide, South Australia, Australia
Australia, Victoria
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Box Hill, Victoria, Australia
Recruiting
Clayton, Victoria, Australia
Withdrawn
Heidelberg, Victoria, Australia
Australia, Western Australia
Recruiting
Nedlands, Western Australia, Australia
Australia
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Bedford Park, Australia
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New Lampton, Australia
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Perth, Australia
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Richmond, Australia
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
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Windsor, Ontario, Canada
Canada, Quebec
Recruiting
Greenfield Park, Quebec, Canada
Recruiting
Quebec City, Quebec, Canada
Withdrawn
Sherbrooke, Quebec, Canada
Chile
Active, not recruiting
Santiago, Chile
Withdrawn
Santiago, Chile
Active, not recruiting
Talca, Chile
Korea, Republic of
Recruiting
Wonju-si, Gangwon-do, Korea, Republic of
Recruiting
Ansan, Geonggi-do, Korea, Republic of
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Anyang-si, Gyeonggi-do, Korea, Republic of
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Daegu, Korea, Republic of
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Guri-si, Gyunggi-do, Korea, Republic of
Recruiting
Incheon, Korea, Republic of
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Seoul, Korea, Republic of
New Zealand
Recruiting
Addington, New Zealand
Recruiting
Auckland, New Zealand
Withdrawn
Dunedin, New Zealand
Recruiting
Hamilton, New Zealand
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New Plymouth, New Zealand
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Newtown, New Zealand
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Palmerston North, New Zealand
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Takapuna, New Zealand
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Tauranga, New Zealand
Peru
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Iquitos, Loreto, Peru
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Bellavista, Peru
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Cercado de Lima, Peru
Terminated
Jesus Maria, Peru
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Lima, Peru
Withdrawn
Piura, Peru
Withdrawn
San Juan de Miraflores, Peru
Withdrawn
San Martin de Porres, Peru
Active, not recruiting
San Miguel, Peru
Withdrawn
Surquillo, Peru
Terminated
Trujillo, Peru
Taiwan
Withdrawn
Kaohsiung, Taiwan
Withdrawn
Taichung City, Taiwan
Withdrawn
Tainan, Taiwan
Withdrawn
Taipei, Taiwan
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Deepak Jain, MD Cubist Pharmaceuticals Medical Monitor
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01598311     History of Changes
Other Study ID Numbers: LCD-CDAD-11-06
Study First Received: May 10, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
CDAD
Clostridium difficile Associated Diarrhea
CDI
Clostridium difficile Infection
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014