A Phase III Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (SSTI and SSTI-related Bacteremia).

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01967225
First received: October 18, 2013
Last updated: April 10, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 for SSTI and 4-6 weeks for bacteremia after the end of treatment ] [ Designated as safety issue: No ]
    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 for SSTI and 4-6 weeks for bacteremia after the end of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Description - Clinical response as per the protocol will be evaulated as Effective,Ineffective and Indeterminate

  • Microbiological response at End of Treatment(EOT) [ Time Frame: 7-21days from the study drug administration ] [ Designated as safety issue: No ]
    Description - Microbiological response protocol will be assessed in accordance with the Guidance for the method of microbological assessment by Japanese Chemotherapy Society

  • Population Pharmacokinetics parameters and Pharmacokinetics/Pharmacodynamics parameters characterized by AUC/MIC [ Time Frame: Multiple time points up to 21 days ] [ Designated as safety issue: No ]
    Description - AUC/MIC means area under the plasma concentration versus time curve / Minimum inhibitory concentration

  • Population Pharmacokinetics parameters and Pharmacokinetics / Pharmacokinetics parameters characterised by Cmax/MIC [ Time Frame: Multiple time points up to 21 days ] [ Designated as safety issue: No ]
    Description - Cmac/MIC means Maximum Concentration / Minimum inhibitory concentration

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Suspected or confirmed Methicillin-resistant Staphylococcus aureus(MRSA) infection
  • Japanese Male and female patients aged 20 years or above

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967225

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 57 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01967225     History of Changes
Other Study ID Numbers: 16099
Study First Received: October 18, 2013
Last Updated: April 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Soft Tissue Infections
Bacterial Infections
Bacteremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014