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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:April 2014
End Date:October 2015

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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
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