A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Completed · Phase 2

Conditions studied: Clostridium Difficile Infection

In brief

The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).

Key facts

Study ID

NCT02092935

Run by

Summit Therapeutics

People needed

100

Starts

2014-04-01

Expected to finish

2015-10-01

Last updated by the study team

2016-10-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent
• Clinical diagnosis of CDAD plus laboratory diagnostic test
• No more than 24 hrs antimicrobial treatment for current CDAD episode
• No more than 3 episodes of CDAD in prior 12 months
• No previous episode of CDAD within 30 days of study enrollment
• Female subjects of childbearing potential must use adequate contraception

You may not qualify if…

• Life-threatening or fulminant colitis
• Concurrent use of antibiotics or any other treatments for CDAD
• History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
• Participation in other Clinical research studies within one month of screening

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Sylmar, California, United States
• Study site — Ventura, California, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Topeka, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Duluth, Minnesota, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Billings, Montana, United States
• Study site — Butte, Montana, United States
• Study site — Sommers Point, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Lima, Ohio, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Seattle, Washington, United States
• Study site — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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