A 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:
NCT01598311
First received: May 10, 2012
Last updated: October 9, 2014
Last verified: October 2014

May 10, 2012
October 9, 2014
May 2012
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01598311 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Clostridium Difficile Infection
  • Drug: CB-183,315
    oral, 250 mg bid for 10 days
    Other Name: Surotomycin
  • Drug: oral vancomycin
    oral, 125 mg qid for 10 days
  • Experimental: CB-183,315 250mg/Surotomycin
    Intervention: Drug: CB-183,315
  • Active Comparator: oral vancomycin, 125 mg
    Intervention: Drug: oral vancomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
608
December 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Mary E Sweeney 6102392764 mary.sweeney@incresearch.com
Contact: Michelle Mobilia 7818601081 michelle.mobilia@cubist.com
Canada,   United States,   Argentina,   Australia,   Taiwan,   Chile,   Korea, Republic of,   New Zealand,   Peru
 
NCT01598311
LCD-CDAD-11-06
No
Cubist Pharmaceuticals
Cubist Pharmaceuticals
Not Provided
Study Director: Deepak Jain, MD Cubist Pharmaceuticals Medical Monitor
Cubist Pharmaceuticals
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP