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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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.
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.
Clinical Response at Test of Cure (TOC)
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.
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 at Test of Cure (TOC)
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
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 at End of Treatment Visit (EOT)
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.
Time frame: 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)
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
Time frame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])
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Unnamed facility
Nagakute, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Yoshida, Fukui, Japan
Unnamed facility
Kasuga, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Miyako-gun, Fukuoka, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 36 more locations
Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.
Time frame: Multiple time points up to 7-14 days after the end of treatment
Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])
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.
Time frame: Baseline and Day 3/4, Day 5/13, EOT, TOC