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

Phase 3

Completed

• Conditions: Skin Diseases, Infectious
• Interventions: Drug: Tedizolid Phosphate (Sivextro, BAY1192631); Drug: Linezolid

• Registration Number: NCT01967225
• Lead Sponsor: Bayer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-22
• Study Start: 2013-11-23
• Primary Completion: 2016-10-28
• Study Completion: 2016-10-28
• Results First Submitted: 2017-10-13
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Results First Posted: 2018-10-04
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tedizolid Phosphate (Sivextro, BAY1192631)	Tedizolid Phosphate (Sivextro, BAY1192631)	Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Linezolid	Linezolid	Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Primary Outcome Measures

Name	Time	Method
Clinical Response at Test of Cure (TOC)	7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia	Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.
Microbiological Response at Test of Cure (TOC)	7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia	Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

Secondary Outcome Measures

Name	Time	Method
Clinical Response at End of Treatment Visit (EOT)	7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration	Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.
Microbiological Response at End of Treatment (EOT)	7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration	Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])	Baseline and Day 3/4, Day 5/13, EOT, TOC	Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 \* (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline.
Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])	Multiple time points up to 7-14 days after the end of treatment	Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.