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

A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

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).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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