A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Summary

The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Timeline

Start

2014-06-23

Primary completion

2016-09-08

Completion

2016-09-08

Publications

• Mikamo H, Tateda K, Yanagihara K, Kusachi S, Takesue Y, Miki T, Oizumi Y, Gamo K, Hashimoto A, Toyoshima J, Kato K. Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. J Infect Chemother. 2018 Sep;24(9):744-752. doi: 10.1016/j.jiac.2018.05.010. Epub 2018 Jun 19.

Drugs

Indications