drugset / Trial / NCT02066402

Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

NCT02066402

Phase 3 Completed 598 enrolled Bayer Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Timeline

Start
2014-03-04
Primary completion
2016-03-06
Completion
2016-04-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Linezolid Other / unclassified 600 mg Intravenous
Subject Tedizolid Small molecule 200 mg Intravenous