A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | December 2014 |
| End Date: | August 2016 |
A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)
The purpose of this research study is to evaluate the safety and effectiveness of
Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
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
We found this trial at
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