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

NCT ID: NCT01967225

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-23
• Study Completion Date: 2016-10-28

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).

Conditions

Skin Diseases, Infectious

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tedizolid Phosphate (Sivextro, BAY1192631)

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

Group Type: EXPERIMENTAL

Tedizolid Phosphate (Sivextro, BAY1192631)

Intervention Type: DRUG

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.

Linezolid

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

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Nagakute, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyoake, Aichi-ken, Japan

Yoshida, Fukui, Japan

Kasuga, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Miyako-gun, Fukuoka, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki, Hyōgo, Japan

Kobe, Hyōgo, Japan

Inashiki-gun, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Kamakura, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Kōshi, Kumamoto, Japan

Tsu, Mie-ken, Japan

Sendai, Miyagi, Japan

Nakagami-gun, Okinawa, Japan

Shimajiri, Okinawa, Japan

Hamamatsu, Shizuoka, Japan

Iwata, Shizuoka, Japan

Numazu, Shizuoka, Japan

Meguro-ku, Tokyo, Japan

Musashimurayama, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shinagawa, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Tachikawa, Tokyo, Japan

Yonago, Tottori, Japan

Shimonoseki, Yamaguchi, Japan

Kofu, Yamanashi, Japan

Fukuoka, , Japan

Gifu, , Japan

Kochi, , Japan

Kumamoto, , Japan

Nagasaki, , Japan

Osaka, , Japan

Shizuoka, , Japan

Shizuoka, , Japan

Toyama, , Japan

Countries

Japan

Other Identifiers

16099

Identifier Type: -

Identifier Source: org_study_id