A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).

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

Details

• Lead Sponsor: Summit Therapeutics
• Treatments: Fidaxomicin

Criteria

Inclusion Criteria:

• Informed Consent

• Clinical diagnosis of CDI plus laboratory diagnostic test

• No more than 30 hours antimicrobial treatment for current CDI episode

• Female subjects of childbearing potential must use adequate contraception

Exclusion Criteria:

• Life-threatening or fulminant CDI

• Subjects with 2 or more episodes of CDI in the previous year

• Females who are pregnant or breastfeeding

• History of inflammatory bowel disease

• Co-administration of potent P-glycoprotein inhibitors

• Participation in other Clinical research studies within one month of screening

• Subjects that the Investigator feels are inappropriate for the study