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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Cubist Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597505
First received: May 10, 2012
Last updated: October 9, 2014
Last verified: October 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 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
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: NCT01597505

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

  Show 181 Study Locations
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: NCT01597505     History of Changes
Other Study ID Numbers: LCD-CDAD-10-07
Study First Received: May 10, 2012
Last Updated: October 9, 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
Infection
Signs and Symptoms
Signs and Symptoms, Digestive
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014