search
Back to results

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

Primary Purpose

Skin Diseases, Infectious

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tedizolid Phosphate (Sivextro, BAY1192631)
Linezolid
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Methicillin Resistant Staphylococcus Aureus,, Skin and soft tissue infection,, Bacteremia,, Tedizolid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tedizolid Phosphate (Sivextro, BAY1192631)

Linezolid

Arm Description

Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))

Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Outcomes

Primary Outcome Measures

Clinical Response at Test of Cure (TOC)
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.
Microbiological Response at Test of Cure (TOC)
Microbiological response was 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 Visit (EOT)
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.
Microbiological Response at End of Treatment (EOT)
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])
Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.
Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])
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.

Full Information

First Posted
October 18, 2013
Last Updated
September 6, 2018
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01967225
Brief Title
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2013 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
October 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious
Keywords
Methicillin Resistant Staphylococcus Aureus,, Skin and soft tissue infection,, Bacteremia,, Tedizolid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tedizolid Phosphate (Sivextro, BAY1192631)
Arm Type
Experimental
Arm Description
Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Intervention Type
Drug
Intervention Name(s)
Tedizolid Phosphate (Sivextro, BAY1192631)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Response at Test of Cure (TOC)
Description
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.
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
Title
Microbiological Response at Test of Cure (TOC)
Description
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
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
Secondary Outcome Measure Information:
Title
Clinical Response at End of Treatment Visit (EOT)
Description
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.
Time Frame
7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
Title
Microbiological Response at End of Treatment (EOT)
Description
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
Time Frame
7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
Title
Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])
Description
Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.
Time Frame
Multiple time points up to 7-14 days after the end of treatment
Title
Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])
Description
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.
Time Frame
Baseline and Day 3/4, Day 5/13, EOT, TOC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-0077
Country
Japan
City
Miyako-gun
State/Province
Fukuoka
ZIP/Postal Code
800-0344
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
City
Koshi
State/Province
Kumamoto
ZIP/Postal Code
861-1196
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
901-2393
Country
Japan
City
Shimajiri
State/Province
Okinawa
ZIP/Postal Code
901-0493
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
City
Iwata
State/Province
Shizuoka
ZIP/Postal Code
438-8550
Country
Japan
City
Numazu
State/Province
Shizuoka
ZIP/Postal Code
410-8555
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Musashimurayama
State/Province
Tokyo
ZIP/Postal Code
208-0011
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0013
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
145-0065
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-8531
Country
Japan
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8605
Country
Japan
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-8520
Country
Japan
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs