Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

Summary

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

Timeline

Start

2011-06-27

Primary completion

2013-06-11

Completion

2013-06-11

Outcome

Met primary endpoint

registry Placebo vs VP 20621 High Dose and Placebo; p <0.0001; Chi-squared NCT01259726 ↗

Publications

• Gerding DN, Meyer T, Lee C, Cohen SH, Murthy UK, Poirier A, Van Schooneveld TC, Pardi DS, Ramos A, Barron MA, Chen H, Villano S. Administration of spores of nontoxigenic Clostridium difficile strain M3 for prevention of recurrent C. difficile infection: a randomized clinical trial. JAMA. 2015 May 5;313(17):1719-27. doi: 10.1001/jama.2015.3725.

Drugs

Indications