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

This study is currently recruiting participants.
Verified April 2014 by Cubist Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597505
First received: May 10, 2012
Last updated: April 8, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597505

Contacts
Contact: Mary E Sweeney 6102392764 mary.sweeney@incresearch.com
Contact: Julie Donovan 7818608162 julie.donovan@cubist.com

  Show 163 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Hernando Patino, 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: April 8, 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
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014