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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 125
- Primary Endpoint
- Clinical Response at Test of Cure (TOC)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tedizolid Phosphate (Sivextro, BAY1192631)
Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Intervention: Tedizolid Phosphate (Sivextro, BAY1192631) (Drug)
Linezolid
Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Intervention: Linezolid (Drug)
Outcomes
Primary Outcomes
Clinical Response at Test of Cure (TOC)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)