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

Study Description

Brief Summary

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 Date	May 10, 2012
Last Update Posted Date	September 02, 2015
Start Date	May 01, 2012
Actual Completion Date	August 01, 2015
Primary Completion Date	July 01, 2015
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

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

Study Design

Brief Title	A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
Official Title	A 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 Type	Interventional
Study Phase	Phase 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 Method	N/A
Study Population	N/A
Intervention	Drug: CB-183,315 oral, 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 oral, 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 oral, 250 mg bid for 10 days
Active Comparator oral vancomycin, 125 mg	Drug : oral vancomycin oral, 125 mg qid for 10 days

Recruitment Information

Recruitment Status:	Completed
Enrollment	608
Completion Date	August 01, 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.
Gender	All
Age	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Argentina Australia Belgium Canada Chile Korea, Republic of New Zealand Peru Taiwan United States

Administrative Information

NCT Number:	NCT01598311
Other Study ID Numbers	4261-006 LCD-CDAD-11-06
Has Data Monitoring Committee	No
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.