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

Completed · Phase 2

Conditions studied: Clostridium Difficile Infection

In brief

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

Key facts

Study ID

NCT02784002

Run by

Summit Therapeutics

People needed

27

Starts

2014-12-01

Expected to finish

2016-08-01

Last updated by the study team

2017-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Laguna Hills — Laguna Hills, California, United States
• Ventura — Ventura, California, United States
• Idaho — Idaho Falls, Idaho, United States
• Butte — Butte, Montana, United States
• New Jersey — Somers Point, New Jersey, United States
• Liberec — Liberec, Czechia
• Pardubice — Pardubice, Czechia
• Praha — Prague, Czechia
• Zlin — Zlín, Czechia
• Leeds — Leeds, United Kingdom
• Liverpool — Liverpool, United Kingdom
• London — London, United Kingdom
• Manchester — Manchester, United Kingdom
• Newcastle Upon Tyne — Newcastle upon Tyne, United Kingdom
• Oxford — Oxford, United Kingdom
• Wigan — Wigan, United Kingdom

Full record on ClinicalTrials.gov

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