CompletedPhase 3

A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

608 participantsStarted 2012-05-16

Plain-language summary

A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Is able to read and sign a consent form; * Is from ≥18 to \<90 years of age; * Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device; * Tests positive for Clostridium difficile; * If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study. Exclusion Criteria: * Has toxic megacolon and/or known small bowel ileus; * Has received treatment with intravenous immune globulin (IVIG) within the past 30 days; * Has 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; * Has received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working; * Has received an investigational vaccine against Clostridium difficile; * Has received an investigational product containing monoclonal antibodies against toxin A or B within 180 days; * Has more than 2 episodes of CDAD within 90 days; * Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy); * Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis; * Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study; * Is unable to discontinue opiate treatment unless on a stable dose; * Has known positiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)

Timeframe: Up to 3 days after EOT (up to Day 13)

Percentage of Participants Experiencing an Adverse Event (AE)

Timeframe: Up to 30 days after EOT (up to Day 40)

Percentage of Participants Discontinuing From Study Treatment Due to an AE

Timeframe: Up to EOT (up to Day 10)

Trial details

NCT IDNCT01598311

SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07-26

Results submitted2018-01-31

View on ClinicalTrials.gov More Clostridium Difficile Infection trials