Clinical trial NCT01967225: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Diseases, Infectious
Keywords: Methicillin Resistant Staphylococcus Aureus,
Skin and soft tissue infection,
Bacteremia,
Tedizolid
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-22
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Clinical Response at Test of Cure (TOC)
timeFrame: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
measure: Microbiological Response at Test of Cure (TOC)
timeFrame: 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 outcomes:
measure: Clinical Response at End of Treatment Visit (EOT)
timeFrame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
measure: Microbiological Response at End of Treatment (EOT)
timeFrame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
measure: Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])
timeFrame: Multiple time points up to 7-14 days after the end of treatment
measure: Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])
timeFrame: Baseline and Day 3/4, Day 5/13, EOT, TOC
Other outcomes:
Locations:
city: Nagakute
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Yoshida
country: Japan
state: Fukui
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Miyako-gun
country: Japan
state: Fukuoka
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Inashiki-gun
country: Japan
state: Ibaraki
city: Tsukuba
country: Japan
state: Ibaraki
city: Kamakura
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Koshi
country: Japan
state: Kumamoto
city: Tsu
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Nakagami-gun
country: Japan
state: Okinawa
city: Shimajiri
country: Japan
state: Okinawa
city: Hamamatsu
country: Japan
state: Shizuoka
city: Iwata
country: Japan
state: Shizuoka
city: Numazu
country: Japan
state: Shizuoka
city: Meguro-ku
country: Japan
state: Tokyo
city: Musashimurayama
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Yonago
country: Japan
state: Tottori
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Kofu
country: Japan
state: Yamanashi
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Nagasaki
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Shizuoka
country: Japan
city: Toyama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: