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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967225
First Posted: October 22, 2013
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
The aim of this study is to see the safety and efficacy of BAY1192631 when it is used for the treatment of skin and soft tissue infections (SSTI) or SSTI-related bacteremia.

Condition Intervention Phase
Skin Diseases, Infectious Drug: Tedizolid(BAY1192631) Drug: Linezolid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical response at Test of Cure (TOC). [ Time Frame: 7-14 days after the end of treatment (EOT) for SSTI and 4-6 weeks after EOT for bacteremia ]
    Description - Clinical response as per the protocol will be evaluated as Clinical cure,Clinical failure and Indeterminate.

  • Microbiological response at Test of Cure (TOC) [ Time Frame: 7-14 days after the end of treatment(EOT) for SSTI and 4-6 weeks after EOT for bacteremia ]
    Description - Microbiological response as per with protocol will be assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.


Secondary Outcome Measures:
  • Clinical response at End of Treatment(EOT) [ Time Frame: 7-21days from the study drug administration ]
    Description - Clinical response as per the protocol will be evaluated as Effective,Ineffective and Indeterminate

  • Microbiological response at End of Treatment(EOT) [ Time Frame: 7-21days from the study drug administration ]
    Description - Microbiological response protocol will be assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 9 weeks ]
  • Change of the lesion size from the screening visit (Only skin and soft tissue infection [SSTI]) [ Time Frame: Multiple time points up to 7-14 days after the end of treatment ]
    Description - Lesion size as per the protocol will be measurement of erythema, edema, or induration, whichever is largest.

  • Reduction ratio of the lesion size from the screening visit to Day 3 or Day 4 visit (Only skin and soft tissue infection [SSTI]) [ Time Frame: 2 days or 3 days after the initial administration ]
    Description - Lesion size as per the protocol will be measurement of erythema, edema, or induration, whichever is largest.


Enrollment: 125
Study Start Date: November 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tedizolid Drug: Tedizolid(BAY1192631)
BAY1192631 solution or tablet 200 mg,once daily,Intravenous (IV) or By Mouth (PO)for 7-21 days
Active Comparator: Linezolid Drug: Linezolid
Linezolid solution or tablet 600 mg,twice daily,every 12 ±3 hours, Intravenous (IV) or By mouth (PO) for 7-21days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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/ mm3
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967225


  Show 70 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01967225     History of Changes
Other Study ID Numbers: 16099
First Submitted: October 18, 2013
First Posted: October 22, 2013
Last Update Posted: October 16, 2017
Last Verified: December 2016

Keywords provided by Bayer:
Methicillin Resistant Staphylococcus Aureus,
Skin and soft tissue infection,
Bacteremia,
Tedizolid

Additional relevant MeSH terms:
Infection
Skin Diseases
Staphylococcal Infections
Soft Tissue Infections
Communicable Diseases
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Bacterial Infections
Linezolid
Methicillin
Torezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action