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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Summit Therapeutics
• Collaborator: Wellcome Trust
• Treatments: Vancomycin

Criteria

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