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

ID: NCT01597505
Status: Completed
Phase: Phase 3
Start Date: May 16, 2012
First Submitted: May 10, 2012
Last Updated: April 17, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: N/A
Conditions: Clostridium Difficile Infection
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Clostridium Difficile Infection

Drug: CB-183,315
Other Names
Surotomycin
Drug: oral vancomycin
Other Names
Phase 3

Tracking Information

First Submitted DateMay 10, 2012
Last Update Posted DateApril 17, 2017
Actual Start DateMay 16, 2012
Actual Completion DateMarch 20, 2015
Actual Primary Completion DateMarch 20, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The proportion of subjects with a clinical outcome of cure [Time Frame: Two days after last dose of study drug]

Original Primary Outcome Measures

Not Available

Current 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]

  • The proportion of subjects who sustain a clinical outcome of cure until Day 50 [Time Frame: 30 days after last dose of study drug]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
Official TitleA Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
Brief Summary

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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
608
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Clostridium Difficile Infection
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: CB-183,315

250 mg bid for 10 days

Other Names
Surotomycin
Drug: oral vancomycin

oral, 125 mg qid for 10 days

Other Names
Study Groups/Cohorts
CB-183,315 250mg/Surotomycin

oral vancomycin, 125 mg

Study Arms
Experimental CB-183,315 250mg/Surotomycin
Drug : CB-183,315
250 mg bid for 10 days

Active Comparator oral vancomycin, 125 mg
Drug : oral vancomycin
oral, 125 mg qid for 10 days

Arm Intervention/Treatment
Experimental CB-183,315 250mg/Surotomycin
Drug : CB-183,315
Active Comparator oral vancomycin, 125 mg
Drug : oral vancomycin

Recruitment Information

Recruitment Status:Completed
Enrollment608
Completion DateMarch 20, 2015
Eligibility 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.
GenderAll
Age18 Years to 90 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Austria
Belgium
Canada
Czech Republic
France
Germany
Hungary
Israel
Italy
Poland
Spain
Sweden
United Kingdom
United States

Administrative Information

NCT Number:NCT01597505
Other Study ID Numbers
4261-005
LCD-CDAD-10-07
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Medical Director
Merck Sharp & Dohme Corp.