A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

Summary

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

Timeline

Start

2014-11-06

Primary completion

2016-03-27

Completion

2016-05-05

Outcome

Met primary endpoint

paper Extended-pulsed fidaxomicin was superior to standard-dose vancomycin for sustained cure of C difficile infection, PMID 29273269 ↗

paper 124 (70%) of 177 patients in the modified full analysis set receiving extended-pulsed fidaxomicin achieved sustained clinical cure 30 days after end of treatment, PMID 29273269 ↗

paper difference 11% [95% CI 1·0-20·7], p=0·030 PMID 29273269 ↗

Publications

• Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.
• Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.

Drugs

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

Indications