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

Phase 3 Completed 210 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

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

Outcome

Missed primary endpoint

paper Non-inferiority was not demonstrated. PMID 29934056 ↗

paper global cure rate was 67.3% (70/104) with fidaxomicin and 65.7% (71/108) with vancomycin: difference 1.2% [95% confidence interval (CI) -11.3-13.7]. PMID 29934056 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Fidaxomicin	Other / unclassified	200 mg	Oral
Comparator	Vancomycin	Other / unclassified	125 mg	Oral