Optimal Treatment for Recurrent Clostridium Difficile

Summary

The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.

Timeline

Start

2016-02-19

Primary completion

2024-08-07

Completion

2024-08-31

Outcome

Outcome not reported

Stopped (Enrollment): “The study sponsor stopped the trial early after enrolling 308 of the target sample size because of a slower than expected recruitment rate.”

Publications

• Background Johnson S, Gerding DN, Li X, Reda DJ, Donskey CJ, Gupta K, Goetz MB, Climo MW, Gordin FM, Ringer R, Johnson N, Johnson M, Calais LA, Goldberg AM, Ge L, Haegerich T. Defining optimal treatment for recurrent Clostridioides difficile infection (OpTION study): A randomized, double-blind comparison of three antibiotic regimens for patients with a first or second recurrence. Contemp Clin Trials. 2022 May;116:106756. doi: 10.1016/j.cct.2022.106756. Epub 2022 Apr 7.

Drugs

Indications