CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Tedizolid Phosphate (Sivextro, BAY1192631) +1 moredrug
Likely dose
Tedizolid Phosphate (Sivextro, BAY1192631) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01967225
NCT01967225Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia)

Bayer·interventional·Posted Oct 22, 2013·Updated Oct 4, 2018

In Brief

A Phase 3 clinical trial evaluating Tedizolid Phosphate (Sivextro, BAY1192631) and Linezolid for Skin Diseases, Infectious. Completed, enrolled 125 participants across 46 sites.

Detailed Summary

The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Diseases, Infectious
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 22, 2013
Enrollment StartNov 23, 2013
Primary CompletionOct 28, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.7 years ago

Interventions

Tedizolid Phosphate (Sivextro, BAY1192631)drug

BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

Linezoliddrug

Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.