Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

Phase 4 Completed 34 enrolled Hartford Hospital Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Timeline

Start: 2012-10-17
Primary completion: 2014-12-15
Completion: 2014-12-15

Publications

Results Housman ST, Thabit AK, Kuti JL, Quintiliani R, Nicolau DP. Assessment of Clostridium difficile Burden in Patients Over Time With First Episode Infection Following Fidaxomicin or Vancomycin. Infect Control Hosp Epidemiol. 2016 Feb;37(2):215-8. doi: 10.1017/ice.2015.270. Epub 2015 Nov 23.

Drugs

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

Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

Summary

Timeline

Publications

Drugs

Indications