Phase 3
N=125
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
Skin Diseases, Infectious
Bottom Line
View on ClinicalTrials.gov: NCT01967225 ↗Enrolled (actual)
125
Serious AEs
8.9%
Results posted
Oct 2018
Primary outcome: Primary: Clinical Response at Test of Cure (TOC) — 86.2; 80.0; 0.0; 6.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tedizolid Phosphate (Sivextro, BAY1192631) (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at Test of Cure (TOC) |
86.2; 80.0; 0.0; 6.9; 10.0; 0.0 | — |
| PRIMARY Microbiological Response at Test of Cure (TOC) |
93.1; 90.0; 100.0; 3.4; 0.0; 0.0 | — |
| SECONDARY Clinical Response at End of Treatment Visit (EOT) |
93.1; 90.0; 50.0; 6.9; 10.0; 0.0 | — |
| SECONDARY Microbiological Response at End of Treatment (EOT) |
93.1; 100.0; 100.0; 6.9; 0.0; 0.0 | — |
| SECONDARY Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI]) |
-62.05; -173.93; -134.31; -317.66; -174.96; -280.69 | — |
| SECONDARY Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI]) |
-32.32; -61.46; -53.30; -94.61; -67.69; -90.09 | — |
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).
Eligibility 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 /= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score >/=10.
Data sourced from ClinicalTrials.gov (NCT01967225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.