Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus … (NCT01967225) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
Japan125 participantsStarted 2013-11-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Clinical Response at Test of Cure (TOC)
Timeframe: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
2
Microbiological Response at Test of Cure (TOC)
Timeframe: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia