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

Bayer

Status and phase: Completed; Phase 3

Conditions: Skin Diseases, Infectious

Treatments: Drug: Linezolid; Drug: Tedizolid Phosphate (Sivextro, BAY1192631)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967225

16099

Details and patient eligibility

About

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).

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Tedizolid Phosphate (Sivextro, BAY1192631)

Experimental group

Description:

Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))

Treatment:

Drug: Tedizolid Phosphate (Sivextro, BAY1192631)

Linezolid

Active Comparator group

Description:

Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Treatment:

Drug: Linezolid