Trial Condition(s):

Skin Diseases, Infectious

Safety and efficacy of BAY1192631 in Japanese patients with Methicillin-resistant Staphylococcus aureus (MRSA) infections

Bayer Identifier:

16099

ClinicalTrials.gov Identifier:

NCT01967225

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

Inclusion Criteria
No Inclusion Criteria Available
Exclusion 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  


 -  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.

Trial Summary

Enrollment Goal
125
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sapporo, Japan, 060-0061

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 983-8520

Status
Completed
 
Locations

Investigative Site

Shinagawa, Japan, 141-8625

Status
Completed
 
Locations

Investigative Site

Tachikawa, Japan, 190-0014

Status
Completed
 
Locations

Investigative Site

Meguro-ku, Japan, 152-8902

Status
Completed
 
Locations

Investigative Site

Musashimurayama, Japan, 208-0011

Status
Completed
 
Locations

Investigative Site

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 455-8530

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 810-0001

Status
Completed
 
Locations

Investigative Site

Kasuga, Japan, 816-0864

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-0008

Status
Completed
 
Locations

Investigative Site

Koshi, Japan, 861-1196

Status
Completed
 
Locations

Investigative Site

Nakagami-gun, Japan, 901-2393

Status
Completed
 
Locations

Investigative Site

Shimajiri, Japan, 901-0493

Status
Completed
 
Locations

Investigative Site

Ota-ku, Japan, 143-8541

Status
Completed
 
Locations

Investigative Site

Kofu, Japan, 400-8506

Status
Completed
 
Locations

Investigative Site

Numazu, Japan, 410-8555

Status
Completed
 
Locations

Investigative Site

Nagakute, Japan, 480-1195

Status
Completed
 
Locations

Investigative Site

Gifu, Japan, 500-8513

Status
Completed
 
Locations

Investigative Site

Tsu, Japan, 514-1101

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 534-0021

Status
Completed
 
Locations

Investigative Site

Shimonoseki, Japan, 750-8520

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 802-0077

Status
Completed
 
Locations

Investigative Site

Ota-ku, Japan, 143-0013

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 231-8682

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 430-0929

Status
Completed
 
Locations

Investigative Site

Amagasaki, Japan, 660-8511

Status
Completed
 
Locations

Investigative Site

Yonago, Japan, 683-8605

Status
Completed
 
Locations

Investigative Site

Kochi, Japan, 781-8555

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Toyoake, Japan, 470-1192

Status
Completed
 
Locations

Investigative Site

Miyako-gun, Japan, 800-0344

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0017

Status
Completed
 
Locations

Investigative Site

Ota-ku, Japan, 145-0065

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 424-8636

Status
Completed
 
Locations

Investigative Site

Yoshida, Japan, 910-1193

Status
Completed
 
Locations

Investigative Site

Inashiki-gun, Japan, 300-0395

Status
Completed
 
Locations

Investigative Site

Tsukuba, Japan, 305-8576

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 420-8527

Status
Completed
 
Locations

Investigative Site

Sagamihara, Japan, 252-0375

Status
Completed
 
Locations

Investigative Site

Iwata, Japan, 438-8550

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 457-8510

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 006-8555

Status
Completed
 
Locations

Investigative Site

Toyama, Japan, 930-0194

Status
Completed
 
Locations

Investigative Site

Setagaya-ku, Japan, 158-8531

Status
Completed
 

Trial Design