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

September 6, 2018 updated by: Bayer

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 810-0001
      • Gifu, Japan, 500-8513
      • Kochi, Japan, 781-8555
      • Kumamoto, Japan, 860-0008
      • Nagasaki, Japan, 852-8501
      • Osaka, Japan, 534-0021
      • Shizuoka, Japan, 424-8636
      • Shizuoka, Japan, 420-8527
      • Toyama, Japan, 930-0194
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
      • Nagoya, Aichi, Japan, 455-8530
      • Nagoya, Aichi, Japan, 457-8510
      • Toyoake, Aichi, Japan, 470-1192
    • Fukui
      • Yoshida, Fukui, Japan, 910-1193
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0864
      • Kitakyushu, Fukuoka, Japan, 802-0077
      • Miyako-gun, Fukuoka, Japan, 800-0344
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0061
      • Sapporo, Hokkaido, Japan, 006-8555
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8511
      • Kobe, Hyogo, Japan, 650-0017
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Tsukuba, Ibaraki, Japan, 305-8576
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
      • Sagamihara, Kanagawa, Japan, 252-0375
      • Yokohama, Kanagawa, Japan, 231-8682
    • Kumamoto
      • Koshi, Kumamoto, Japan, 861-1196
    • Mie
      • Tsu, Mie, Japan, 514-1101
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 901-2393
      • Shimajiri, Okinawa, Japan, 901-0493
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-0929
      • Iwata, Shizuoka, Japan, 438-8550
      • Numazu, Shizuoka, Japan, 410-8555
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Musashimurayama, Tokyo, Japan, 208-0011
      • Ota-ku, Tokyo, Japan, 145-0065
      • Ota-ku, Tokyo, Japan, 143-8541
      • Ota-ku, Tokyo, Japan, 143-0013
      • Setagaya-ku, Tokyo, Japan, 158-8531
      • Shinagawa, Tokyo, Japan, 141-8625
      • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Tachikawa, Tokyo, Japan, 190-0014
    • Tottori
      • Yonago, Tottori, Japan, 683-8605
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-8520
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tedizolid Phosphate (Sivextro, BAY1192631)
Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Drug: Tedizolid Phosphate (Sivextro, BAY1192631)
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.
Active Comparator: Linezolid
Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Drug: Linezolid
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Response at Test of Cure (TOC)
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 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.
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)
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 was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Response at End of Treatment Visit (EOT)
Time Frame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
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.
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)
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 was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
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])
Time Frame: Multiple time points up to 7-14 days after the end of treatment
Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.
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])
Time Frame: Baseline and Day 3/4, Day 5/13, EOT, TOC
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.
Baseline and Day 3/4, Day 5/13, EOT, TOC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16099 (Other Identifier: City of Hope Medical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings