Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections

• Status: Completed
• Trial end date: 2016-10-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Linezolid; Methicillin; Tedizolid; Tedizolid phosphate; Torezolid

Criteria

Inclusion Criteria

• Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection

• Japanese Male and female patients aged 18 years or above

• Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SSTI (skin and soft tissue infection)-derived MRSA bacteremia suspected

Exclusion Criteria:

• Having received any systemic antibacterial potentially effective against MRSA for >/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for >/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to MRSA.

• Moribund clinical condition such as death likely within the first 3 days of a study drug treatment

• History of significant allergy or intolerance to linezolid or BAY1192631

• Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell count < 200/μL

• Chronic treatment with immunosuppressive drugs

• Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments

• Current or anticipated neutropenia with neutrophil count < 1,000/ mm^3

• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >/= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score >/=10.